[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asthma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,238,0,25,[9,45,74,102,129,149,178,202,223,250,268,288,313,337,362,388,411,438,466,490,509,527,548,572,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609791","phase-2-a-study-to-evaluate-brenipatide-compared-with-placebo-in-adult-participants-with-uncontrolled-moderate-to-severe-asthma-100609791",false,"NCT07219173","A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma","A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma","RENEW-Asthma","Inclusion Criteria:\n\n* Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.\n* Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.\n* History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  * An established diagnosis of occupational asthma\n* Known pre-existing, clinically important lung condition other than asthma, including but not limited to:\n\n  * chronic respiratory infection\n  * bronchiectasis\n  * pulmonary fibrosis\n  * allergic bronchopulmonary aspergillosis\n  * emphysema\n  * chronic bronchitis\n  * eosinophilic granulomatosis with polyangiitis\n  * chronic obstructive pulmonary disease, and\n  * other mimics of asthma, that is, vocal cord dysfunction.\n* Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.","ALL","18 Years","75 Years",{"count":22,"type":23},531,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.\n\nStudy participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.",[29],"Asthma",[31],"Incretin","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2025-10-22",{"date":40,"type":23},"2028-06",{"name":42,"class":43},"Eli Lilly and Company","INDUSTRY",121,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100652858","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-gsk5784283-compared-with-placebo-in-participants-with-uncontrolled-asthma-persist-asthma-1-100652858","NCT07780643","A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-1)","Inclusion Criteria:\n\n* Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).\n* Participants aged 12 to 80 years at the time of signing the informed consent.\n* Male or eligible female participants:\n\n  * Female participants:\n\n    * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n      i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.\n* If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.\n* A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.\n* Evidence of variable airflow obstruction consistent with asthma.\n* Documented history of asthma exacerbation within 12 months prior to Visit 1.\n* A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).\n* At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \\[LABA\\], Leukotriene receptor antagonists \\[LTRA\\], theophylline, Long-acting muscarinic agonists \\[LAMA\\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.\n* Uncontrolled asthma based on ACQ-5 score.\n\nExclusion Criteria:\n\n* Any concomitant respiratory disease that in the opinion of the investigator and\u002For medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.\n* History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association (NYHA) class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.\n* History of an unresolved clinically significant infection within 30 days prior to Visit 1.\n* A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma.\n* Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.\n* Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).\n* Current smokers (tobacco and\u002For marijuana), current users of vaping products\u002Felectronic-cigarettes or participants with a smoking history \\>=10 pack-years.","12 Years","80 Years",{"count":55,"type":23},514,[57],"PHASE3","The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.",[29],[29,61,62,63,64],"Felcorekibart","GSK5784283","Placebo","Standard of care","NOT_YET_RECRUITING","2026-08-19",{"date":35,"type":36},{"date":69,"type":23},"2026-08-31",{"date":71,"type":23},"2029-10-11",{"name":73,"class":43},"GlaxoSmithKline",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100460178","registry-of-asthma-characterization-and-recruitment-3-racr3-100460178","NCT05272241","Registry of Asthma Characterization and Recruitment 3 (RACR3)","Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)","RACR3","Inclusion Criteria:\n\n1. Participant is either:\n\n   1. At least 18 years old, willing and able to provide informed consent at the time of enrollment\n   2. Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment\n2. Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)\n\nExclusion Criteria:\n\n1. Participant does not speak English or Spanish and\u002For guardian does not speak English or Spanish\n2. Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up\n3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study\n\nParticipants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy.\n\nPotential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.",true,{"count":84,"type":23},1500,"7 Years","OBSERVATIONAL","This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.",[29],[29,90,91,92],"Allergy","CAUSE","RACR",{"date":35,"type":36},{"date":95,"type":36},"2022-05-06",{"date":97,"type":23},"2027-05",{"name":99,"class":100},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",7,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100627125","phase-3-roll-over-study-for-participants-who-have-completed-a-previous-clinical-study-with-benralizumab-fasenra-and-benefit-from-continued-treatment-100627125","NCT07444567","Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment","ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","ROSY-F","Inclusion Criteria:\n\n* 1\\. Provision of signed and dated written ICF.\n\n  2\\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.\n* 3\\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment.\n* 4\\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment.\n* 5\\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.\n\nExclusion Criteria:\n\n* 1\\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab.\n* 2\\. Participants who are planning to use live\u002Flive-attenuated vaccines.\n* 3\\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available.\n* 4\\. Participants with any medical condition (such as cancer or viral infections \\[hepatitis\\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.\n* 5\\. Concurrently enrolled in any clinical study (other than a parent study).\n* 6\\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.\n* 7\\. Local access to commercially available benralizumab.","6 Years",{"count":112,"type":23},230,[57],"The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.",[29,116,117],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)",[29,119,117],"Eosinophilic Granulomatosis with Polyangiitis (EGPA)","2026-08-18",{"date":66,"type":36},{"date":123,"type":36},"2026-07-24",{"date":125,"type":23},"2030-01-03",{"name":127,"class":43},"AstraZeneca",45,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":136,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100579860","phase-3-tqc2731-clinical-trial-for-the-treatment-of-severe-asthma-with-injection-100579860","NCT06829784","TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection","A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma","Inclusion Criteria:\n\n* Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;\n* Age 18 \\~ 75 years old, gender is not limited;\n* Documented physician diagnosis of asthma at least 12 months prior to Visit 1;\n* Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;\n* There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;\n* There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment.\n* Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed.\n\nExclusion Criteria:\n\n* Have a clinically significant lung disease other than asthma；\n* Pre-existing autoimmune disease;\n* A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;\n* Any disease that has not been determined to be stable by the investigator；\n* Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study.\n* Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \\\u003C10 pack-years had quit smoking less than 6 months before interview 1);\n* Other factors determined by the investigator that subjects were not suitable to participate in the study.",{"count":137,"type":23},660,[57],"This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 trial participants are expected to be enrolled, with trial participants randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.",[29],{"date":66,"type":36},{"date":143,"type":36},"2025-03-21",{"date":145,"type":23},"2028-03",{"name":147,"class":43},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.",101,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100498951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qvm149-indacaterol-acetate--glycopyrronium-bromide--mometasone-furoate-versus-salmeterol-xinafoatefluticasone-propionate-in-children-from-12-years-to-less-than-18-years-of-age-with-asthma-100498951","NCT05776927","A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate \u002F Glycopyrronium Bromide \u002F Mometasone Furoate) Versus Salmeterol Xinafoate\u002FFluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate \u002F Glycopyrronium Bromide \u002F Mometasone Furoate) Compared to Salmeterol Xinafoate\u002FFluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","Key Inclusion criteria:\n\n* Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit\n* Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.\n* Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening\n* Participants must be symptomatic \u002F inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening\n* Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol\u002F180-360 μg albuterol at run-in visit\n* Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society\u002FEuropean Respiratory Society (ATS\u002FERS) 2019 criteria at both run-in and before randomization\n\nKey Exclusion criteria:\n\n* Participants who have had a severe asthma attack\u002Fexacerbation requiring systemic steroids OR hospitalization (\\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack\u002Fexacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation\n* Participants who have ever required intubation for a severe asthma attack\u002Fexacerbation\n* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis\n* Participants with Type I diabetes or uncontrolled Type II diabetes\n* Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in\n* Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months\n* Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for males and \\> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)\n* Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria\n* Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","17 Years",{"count":158,"type":23},188,[57],"The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate \u002F glycopyrronium bromide \u002F mometasone furoate (QVM149) compared to salmeterol xinafoate \u002F fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.",[29],[29,163,164,165,166,167,168,169],"Adolescent","QVM149","Pediatric","LABA","LAMA","ICS","Triple Combination",{"date":66,"type":36},{"date":172,"type":36},"2026-08-04",{"date":174,"type":23},"2029-01-30",{"name":176,"class":43},"Novartis Pharmaceuticals",3,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100482471","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100482471","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","11 Years",{"count":187,"type":23},200,[57],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[29],[29,165,192,193,194],"Breezhaler","QMF149","Budesonide",{"date":66,"type":36},{"date":197,"type":36},"2023-05-11",{"date":199,"type":23},"2028-05-30",{"name":176,"class":43},64,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":185,"enrollmentInfo":209,"targetDuration":4,"studyType":24,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100456356","phase-2-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-glycopyrronium-bromide-in-children-6-to-less-than-12-years-with-asthma-100456356","NCT05222529","Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma","A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.","Inclusion Criteria:\n\n* Confirmed diagnosis of asthma for at least 6 months\n* Signed informed consent by parent(s)\u002Flegal guardian(s) and assent by the pediatric participant (depending on local requirements)\n* Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in\n* Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the End of Run-in (Visit 30), the visit can be rescheduled once within 5 days from the previous attempt.\n* FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase \\> and\u002For = 12% (performed according to American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) 2019 guidelines). All participants must perform a reversibility test at start of Run-in. If reversibility is not demonstrated at Run-in, it may be attempted at up to two ad hoc, unscheduled separate visits within 5 days from previous attempt. If reversibility is still not demonstrated after repeated assessment participants must be screen failed\n* Demonstrated acceptable inhaler use technique for Diskus\u002FAccuhaler (prior to run-in) and Breezhaler (prior to randomization) and able to complete spirometry procedures prior to randomization.\n* A parent\u002Flegal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the participant.\n* Parents\u002Flegal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic participant diary\n* Female participants of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study using effective contraceptive methods. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.\n\nExclusion Criteria:\n\n* Systemic corticosteroid use for any reason within 3 months of Run-in\n* Participants on low to medium mono ICS alone\n* Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and\u002For in the four weeks prior to the Run-in visit\n* Participants who have had an asthma attack\u002Fexacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than 3 separate exacerbations in the 12 months preceding the Screening visit\n* Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)\n* Participants with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened)\n* Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease) of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 6 weeks of Screening (Visit 1)\n* History of Type I diabetes or uncontrolled Type II diabetes\n* Participants who are sexually active at screening\n* Hemoglobin levels outside normal ranges at Run-in (Visit 20)\n* Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study participation, do not agree to the use of contraception as defined in the inclusion criteria.\n\nAdditional protocol-defined inclusion \u002F exclusion criteria may apply.",{"count":210,"type":23},42,[26],"The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety\u002Ftolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol\u002Fmometasone\u002Fglycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.",[29],[215],"Glycopyrronium, pediatric, asthma, Breezhaler, PK",{"date":66,"type":36},{"date":218,"type":36},"2022-08-29",{"date":220,"type":23},"2027-08-30",{"name":176,"class":43},23,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":24,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":249},"100631461","phase-2-efficacy-of-l-menthol-on-breathlessness-in-asthma-100631461","NCT07500974","Efficacy of L-menthol on Breathlessness in Asthma","Effect of L-menthol on Breathlessness and Exercise Capacity in Asthma: a Randomized Crossover Trial","Ment-Astma","Inclusion Criteria:\n\n* the subject has given written consent to participate in the study\n* physician diagnosis of Asthma according to international guidelines\n* mMRC (modified Medical Research Council) score of 1 or above\n* age 18 years or older\n* able to cycle\n* able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators.\n\nExclusion Criteria:\n\n* resting peripheral oxygen saturation (SpO2) \\\u003C 92%\n* hospitalization or clinical instability during the last four weeks\n* treatment with supplementary oxygen at rest or during exercise\n* contraindication to exercise testing in accordance with clinical practice guidelines\n* expected survival shorter than six months as judged by the Investigator\n* medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.",{"count":232,"type":23},20,[26],"The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.",[29],[237,238,239,240],"breathlessness","asthma","exercise capacity","CPET","2026-08-17",{"date":66,"type":36},{"date":244,"type":36},"2026-05-07",{"date":97,"type":23},{"name":247,"class":248},"Region Skane","OTHER",2,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":257,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100548316","a-translational-study-to-describe-clinical-characteristics-biomarkers-and-to-identify-phenotypes-and-endotypes-associated-with-differential-outcomes-in-chinese-population-100548316","NCT06419413","A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population","A Transnational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population","Inclusion Criteria:\n\n* Age 18 to 75 years of age\n* acceptable FEV1 (according to ATS and ERS)\n* compliance with study procedures All Asthma Cohorts\n* physician diagnosed Asthma greater or equal to 3 months prior to screening visit\n\nExclusion Criteria:\n\n* history of alcohol or drug abuse within the past year\n* pregnant at time of an assessment\n* has an altered mental status at the time of informed consent\n* receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer\n* history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments\n* terminal diseases and\u002For organ failure or participants otherwise considered not appropriate for the study participation\n* Receipt LTRAs or 5-lipoxygenase (5-LO) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to baseline, whichever is longer.",{"count":258,"type":23},355,"A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population",[29],{"date":120,"type":36},{"date":263,"type":36},"2024-01-08",{"date":265,"type":23},"2026-10-08",{"name":127,"class":43},21,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":275,"targetDuration":4,"studyType":24,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":249},"100652484","phase-3-a-study-to-learn-about-the-study-medicine-called-tilrekimig-in-people-with-severe-asthma-100652484","NCT07772921","A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA","Inclusion Criteria\n\nMust meet the following asthma criteria:\n\n1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and \u002F or local guidelines.\n2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\\\u003C24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma with within 12 months of the screening visit.\n3. Positive bronchodilator responsiveness of FEV1 or FVC \\>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol\u002Falbuterol (or equivalent SABA) at least once for spirometry conducted during screening period.\n\n   Other Inclusion Criteria:\n4. Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and \u002F or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to, chronic obstructive pulmonary disease, other emphysematous lung disease such as alpha-1 antitrypsin disease, cystic fibrosis, emphysema, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.\n2. Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\n   Prior\u002FConcomitant Therapy:\n3. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.\n4. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40\u002FOX40L, IL-13, IL-33 \u002F ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.\n5. Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).\n6. Bronchial thermoplasty within the previous 24 months.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n7. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.",{"count":276,"type":23},1100,[57],"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.\n\nThe study is seeking participants who:\n\n* Have a history of severe asthma for at least 12 months\n* Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic.\n\nThe study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.",[29],"2026-08-14",{"date":66,"type":36},{"date":283,"type":23},"2026-08-24",{"date":285,"type":23},"2029-09-04",{"name":287,"class":43},"Pfizer",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":296,"maxAge":185,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100517903","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-tezepelumab-compared-with-placebo-in-children-5-to--12-years-old-with-severe-asthma-100517903","NCT06023589","A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to \u003C 12 Years Old With Severe Asthma","A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to \u003C 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)","HORIZON","Inclusion Criteria:\n\n1. Written informed consent from (ICF) at least one parent\u002Fcaregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.\n2. Participants must be 5 to \\\u003C 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.\n3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.\n4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n6. Supportive evidence of asthma as documented by one of the following:\n\n   1. Post-BD (albuterol\u002Fsalbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol\u002Fsalbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.\n\n      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:\n   2. Post-BD responsiveness of FEV1 ≥ 10%.\n   3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg\u002FmL.\n   4. PEF average daily diurnal variability \\> 13% over a 2-week period.\n   5. Variability of FEV1 ≥ 12% between any two clinical visits.\n   6. Positive exercise challenge test (defined as a fall in FEV1 of \\> 12%).\n   7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.\n7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.\n8. Pre-BD FEV1 \\>50% and ≤ 95%PN OR FEV1\u002Fforced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.\n9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:\n\n   1. ACQ-IA score ≥ 1.5 at least once during Screening\u002FRun-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.\n   2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening\u002FRun-in period.\n   3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening\u002FRun-in period.\n   4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening\u002FRun-in period.\n10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).\n\nExclusion Criteria:\n\n1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.\n2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.\n4. Change in ICS dose within 1 month prior to Visit 1.\n5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.","5 Years",{"count":298,"type":23},231,[57],"To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.",[29],[29,303,304,305],"Uncontrolled Asthma","Severe Uncontrolled Asthma","Human monoclonal antibody (IgG2λ) cytokine",{"date":241,"type":36},{"date":308,"type":36},"2023-08-24",{"date":310,"type":23},"2030-08-23",{"name":127,"class":43},147,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":4,"leadSponsor":335,"locationsCount":249},"100083273","personalized-environment-and-genes-study-100083273","NCT00341237","Personalized Environment and Genes Study","* INCLUSION CRITERIA\n\nIn order to be eligible for participation in this study, an individual must meet all of the following criteria:\n\n* Adults greater than or equal to 18 years of age\n* If female, must not be (self-reported as) pregnant. At the time of enrollment, a pregnancy test will only be done at the PI s discretion.\n* Able to understand and provide written informed consent\n* Able to come to the NIEHS Clinical Research Unit (CRU) for enrollment and study-related visits\u002Fprocedures.\n\nEXCLUSION CRITERIA\n\nAn individual who does not meet the inclusion criteria listed above is excluded from participation in this study.","120 Years",{"count":321,"type":23},25000,"Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.\n\nThe Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and\u002For any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.\n\nTo expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.\n\nWhole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.\n\n...",[324,325,29],"Diabetes","Heart Disease",[327,328,329,330,331],"Genotype","Phenotype","Environmental Factor","Single Nucleotide Polymorphism","Natural History",{"date":241,"type":36},{"date":334,"type":36},"2010-05-26",{"name":336,"class":100},"National Institute of Environmental Health Sciences (NIEHS)",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"100628007","phase-3-a-study-of-efficacy-and-safety-of-depemokimab-compared-with-placebo-in-adults-and-adolescents-with-at-risk-type-2-asthma-100628007","NCT07456033","A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma","The MODIFY Study: A Phase 3b\u002F4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks","MODIFY","Inclusion Criteria:\n\n* Adults and adolescents \\>=12 years of age, at the time of signing the informed consent\u002Fassent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \\>=18 years of age.\n* Participants must have a documented physician diagnosis of asthma for \\>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines\n* Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.\n\n  * Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)\u002F Long-acting beta2-adrenergic receptor agonist (LABA).\n* A well-documented requirement for treatment with low to medium dose ICS\u002FLABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy\u002FSingle Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.\n\n  * Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS\u002FLABA.\n* Sex and Contraceptive\u002FBarrier Requirements Male or eligible female Participants:\n\n  * Male Participants: Contraception for male participants with female partners is not required.\n  * Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n  * Is a participant of nonchildbearing potential (PONCBP) OR\n  * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.\n  * A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.\n  * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n  * The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Capable of giving signed informed consent\u002Fassent as which includes compliance with the requirements Randomization inclusion criteria-\n* Type 2 high disease at risk of asthma exacerbations as defined by either:\n\n  * An elevated peripheral blood eosinophils (EOS) count of \\>=500 cells\u002Fmicroliter (μL) at screening or \\>=500 cells\u002FμL in the last 3 months prior to the screening visit.\n\nOR\n\n* An elevated peripheral blood EOS count of \\>=300 cells\u002FμL at screening OR \\>=300 cells\u002FμL in the last 3 months prior to the screening visit AND\n\n  * Fractional exhaled nitric oxide \\>=35 parts per billion (ppb) at screening. OR\n  * Documented current Chronic Rhinosinusitis with Nasal Polyps.\n\nExclusion Criteria:\n\n* Participants have had 3 or more exacerbations in the last year prior to Visit 1.\n* Participants on maintenance OCS or high dose ICS\u002FLABA for asthma.\n* Participants with a duration of asthma greater than (\\>)20 years.\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.\n* Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.\n* Participants who developed an exacerbation within 4 weeks before screening.\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.\n* A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.\n* Current smokers or former smokers with a smoking history of \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] \\* number of years smoked) and vapers.\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab.\n* Participants who are pregnant or breastfeeding.\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations.\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.\n\nLiver safety exclusion criteria:\n\n* Alanine aminotransferase (ALT) \\>2\\* Upper limit of normal (ULN).\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN.\n* Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n\nCardiac safety exclusion criteria:\n\n* Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) \\>=450 millisecond (msec) or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12-lead ECG machine read at Visit 1.\n* Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator.\n\nRandomization exclusion criteria:\n\n* ECG Assessment: QTcF \\>=450 msec or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1.\n* ALT \\>2\\*ULN.\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\\u003C=1.5\\*ULN.\n* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable.\n* Maintenance Asthma Therapy: Any changes in the dose or regimen of baseline ICS and\u002For additional controller medication (except for treatment of an exacerbation) during the run-in period.",{"count":346,"type":23},456,[57],"The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).",[29],[351,352,343,353],"GSK3511294","Depemokimab","Type 2 asthma","2026-08-13",{"date":241,"type":36},{"date":357,"type":36},"2026-03-13",{"date":359,"type":23},"2030-09-23",{"name":73,"class":43},17,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":4,"enrollmentInfo":370,"targetDuration":372,"studyType":86,"phases":4,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100635705","a-study-evaluating-disease-characteristics-and-outcomes-in-participants-with-asthma-in-routine-clinical-practice-100635705","NCT07556159","A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice","A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma","AIRITY","Inclusion Criteria:\n\nApplicable for Part 1 participants:\n\n* Age 6 years and older, at the time of signing the informed consent\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n\nApplicable for Part 2 participants:\n\n* Age 18 years and older, at the time of signing the informed consent.\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n* Participants must meet the criteria for at least one of the cohorts below:\n\nA) Asthma control cohorts\n\n1. ACQ-5 \\>= 1.5\n2. ACQ-5 \\\u003C 1.5 (B) Type-2 biomarker cohorts\n3. Elevated T2 biomarkers (B1: Type-2-high cohort)\n4. Low T2 biomarkers (B2: Type-2-low cohort)\n\nParticipants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):\n\n* Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure\n* Participants with moderate\u002Fsevere cognitive impairment.\n* Participants with moderate\u002Fsevere cardiac disease.\n* Participants on immunosuppressive medication for a chronic condition.\n* Participation in other interventional and noninterventional clinical study (currently or in the past 3 months)\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":371,"type":23},2500,"24 Months","The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life.\n\nThe study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.",[29],[376,377,378],"Cross-Sectional","Multicenter","Inhaled Corticosteroids","2026-08-12",{"date":354,"type":36},{"date":382,"type":36},"2026-04-01",{"date":384,"type":23},"2029-04-04",{"name":386,"class":43},"Sanofi",59,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100623671","real-world-evaluation-of-tezepelumab-for-chronic-rhinosinusitis-with-nasal-polyps-in-russia-100623671","NCT07399665","ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia","Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab","ARES","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older at the time of signing the ICF.\n2. Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.\n3. Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use \u002F nasal polyps surgery (or information about contraindications \u002F intolerance to).\n4. Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks.\n5. The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.\n6. Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.\n7. SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.\n8. Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.\n9. Provision of signed and dated written informed consent.\n10. Participants are able to read, understand and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\n1. Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.\n2. Administration of concurrent biologic drug for CRSwNP \u002F asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior biologic drug is ≥ 60 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less.\n3. Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.\n4. Pregnancy or lactation period.",{"count":397,"type":23},110,"ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).",[400,29],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",[402,403],"Tezepelumab","CRSwNP",{"date":354,"type":36},{"date":406,"type":36},"2025-12-25",{"date":408,"type":23},"2028-03-31",{"name":127,"class":43},10,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":156,"enrollmentInfo":419,"targetDuration":4,"studyType":24,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},"100539732","phase-3-evaluating-the-efficacy-and-safety-of-pt027-compared-with-pt007-administered-as-needed-in-participants-12-to--18-years-of-age-with-asthma-100539732","NCT06307665","Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to \u003C 18 Years of Age With Asthma","A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to \u003C 18 Years of Age With Asthma (ACADIA)","ACADIA","Inclusion Criteria:\n\n* Confirmed clinical diagnosis of asthma at least 12 months.\n* Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month\n\n  1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)\n  2. Low-to-high-dose ICS or ICS\u002Flong-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline\n* Receiving inhaled short-acting β2-agonist (SABA) as needed.\n* A documented history of at least one severe asthma exacerbation within 12 months.\n* Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.\n* Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.\n* Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.\n* Participants must adhere to protocol specific contraception methods.\n* Negative urine pregnancy test for participants of childbearing potential.\n* Have a BMI \\\u003C 40 kg\u002F m\\^2.\n* Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.\n\nExclusion Criteria:\n\n* Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).\n* Experienced \\> 3 severe asthma exacerbations within 12 months before screening.\n* Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.\n* Upper respiratory infection involving antibiotic treatment not resolved.\n* Current smokers, former smokers with \\> 10 pack-years history, or former smokers who stopped smoking \\\u003C 6 months (including all forms of tobacco, e-cigarettes \\[vaping\\], and marijuana).\n* Other significant lung disease, including regular or occasional use of oxygen.\n* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.\n* Cancer not in complete remission for at least 5 years.\n* History or hospitalization for psychiatric disorder or attempted suicide within one year.\n* Significant abuse of alcohol or drugs, in the opinion of the investigator.\n* Oral corticosteroid(s) (OCS)\u002FSCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS\u002FSCS (≥ 3 weeks use in 3 months prior to Visit 1).\n* Use of any oral SABAs within one month.\n* Having a known or suspected hypersensitivity to albuterol\u002Fsalbutamol, or budesonide and\u002For their excipients.",{"count":420,"type":23},440,[57],"The purpose of this study is to compare the effect of budesonide\u002Falbuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.",[29],[425,426,427,428,429,430],"Fast-acting β2-agonist","Metered-Dose Inhaler (MDI)","Bronchodilatory","Inhaled corticosteroids","Anti-inflammatory","Rescue Therapy",{"date":354,"type":36},{"date":433,"type":36},"2024-05-20",{"date":435,"type":23},"2027-10-13",{"name":127,"class":43},150,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":445,"enrollmentInfo":446,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":448,"conditions":449,"keywords":454,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":4,"leadSponsor":464,"locationsCount":465},"100143840","study-of-the-effect-of-innate-on-the-inflammatory-response-to-endotoxin-100143840","NCT01143480","Study of the Effect of Innate on the Inflammatory Response to Endotoxin","Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin","* INCLUSION CRITERIA:\n* Male or female 18 years of age or older\n* Participants must be able to understand and provide written informed consent to participate in the study\n* Participants must be able to travel to the CRU\n* Willing and able to fast after midnight the night prior to their study appointment.\n* Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).\n\nEXCLUSION CRITERIA:\n\n* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)\n* Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit\n* Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)\n* Use of immunosuppressants or other immune-modifying drugs \\[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\\], Monoclonal antibodies \\[e.g., infliximab (Remicade)\\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)\n* Current treatment for cancer with chemotherapy or radiation\n* Confirmed or suspected immunosuppressive or immunodeficient condition\n* GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies\n* Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \\>200 ng\u002FmL at visit)\n* Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit\n* Body weight \\\u003C 50 kg (\\\u003C110 lbs)\n* Temperature \\> 37.6 C; blood pressure \\\u003C 90\u002F50 mm Hg or \\> 170\u002F95 mm Hg; pulse rate \\\u003C 50 or \\>100 beats\u002Fminute\n* Pregnant or suspected pregnancy\n* Chronic Kidney Disease\n\nThe PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.","100 Years",{"count":447,"type":23},725,"Background:\n\n\\- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers.\n\nObjectives:\n\n\\- To examine how specific genes and proteins in blood cells respond to environmental exposures.\n\nEligibility:\n\n\\- Healthy volunteers between 18 and 45 years of age.\n\nDesign:\n\n* The study will involve one visit of 45 to 60 minutes.\n* Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking.\n* Participants will provide a blood sample for research purposes.",[29,450,451,452,453],"Atherosclerosis","Metabolic Syndrome","Insulin Resistance","Cancer",[455,456,331,457,458],"Endotoxin","Innate Immunity","Healthy Volunteer","HV","2026-08-06",{"date":461,"type":36},"2026-08-07",{"date":463,"type":36},"2012-07-30",{"name":336,"class":100},1,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":24,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100552297","phase-3-a-study-to-investigate-efficacy-and-safety-of-pt027-compared-with-pt007-in-symptomatic-chinese-adults-with-asthma-100552297","NCT06471257","A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma","A Randomized, Double-blind, Multicentre, Event-driven, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Symptomatic Chinese Adults With Asthma (BAIYUN)","BAIYUN","Inclusion Criteria:\n\n1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1\n2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1\n3. Pre-bronchodilator FEV1 of ≥ 40% to \\\u003C 90% predicted normal value for adults.\n4. Documented reversibility to albuterol\n5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1\n6. ACQ-7 score ≥ 1.5 assessed at Visit 1\n7. ACQ-5 score ≥ 1.5 assessed at Visit 2\n8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months\n9. Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2\n10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited\n11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator\n12. BMI \\\u003C 40 kg\u002Fm2\n13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential\n14. Women of childbearing potential must agree to prevent pregnancy\n15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments\n\nExclusion Criteria:\n\n1. Chronic obstructive pulmonary disease or other significant lung disease\n2. Oral\u002FSCS use (any dose) within 6 weeks before Visit 1\n3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1\n4. Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication\n5. Current smokers, former smokers with \\> 10 pack-years history, or former smokers who stopped smoking \\\u003C 6 months before Visit 1\n6. Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1\n7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1\n8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1\n9. Clinically significant laboratory abnormalities\n10. Historical or current evidence of a clinically significant disease\n11. Cancer not in complete remission for at least 5 years before Visit 1\n12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity\n13. Have a known or suspected hypersensitivity to albuterol\u002Fsalbutamol, or budesonide and\u002For their excipients\n14. Inability to abstain from protocol-defined prohibited medications during the study\n15. Having received a live attenuated vaccination within 7 days of Visit 1\n16. Currently pregnant or breastfeeding\n17. Participants who experience \\> 1 asthma exacerbation during the screening period",{"count":475,"type":23},1000,[57],"An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.",[29],[29,480,481],"Chinese asthma population","PT027","2026-08-05",{"date":461,"type":36},{"date":485,"type":36},"2024-06-17",{"date":487,"type":23},"2027-10-04",{"name":127,"class":43},102,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":499,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":465},"100419597","phase-4-measuring-the-effect-of-dupilumab-treatment-on-mucociliary-clearance-mcc-in-subjects-with-moderate-to-severe-asthma-100419597","NCT04743791","Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma","A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma","Inclusion Criteria:\n\n* Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \\\u003C90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller\n* Age \\> 18\n* Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)\n* Reversibility \\>\u002F= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening\n* FEV1\u002FForced Vital Capacity (FVC)\\\u003C75%\n* Blood Eosinophils (EOS) \\>300 cells per mm3\n* Exhaled Nitric Oxide (FeNO) \\>25 parts per billion (ppb)\n* Asthma Control Test (ACT) score \\\u003C20\n\nExclusion Criteria:\n\n* Pregnant, nursing, or unwilling to test for pregnancy\n* Current smoker or \\>10 pack year smoking history\n* Body Mass Index (BMI)\\>37\n* Respiratory infection in the last 30 days\n* Use of antibiotics or oral prednisone in the last 30 days\n* Current or previous use of dupilumab\n* Current or recent use of anti-IL-5 therapies\n* Any other criteria that place the subject at unnecessary risk\n* Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)\n* History of non-skin cell cancer in the last 5 years\n* Drug or alcohol addiction in the last 5 years\n* Any other uncontrolled disease",{"count":498,"type":23},30,[500],"PHASE4","Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.",[29],{"date":459,"type":36},{"date":505,"type":36},"2022-10-17",{"date":40,"type":23},{"name":508,"class":248},"Sally E. Wenzel MD",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":516,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":465},"100539111","comparison-of-microglial-activation-in-severe-asthma-and-healthy-controls-100539111","NCT06299592","Comparison of Microglial Activation in Severe Asthma and Healthy Controls","MAIA-SC","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Individuals with no health concerns that might affect the outcome of the study\n* Age 18-75 years of age\n* Ability to tolerate a simulated MRI brain scanning session\n* In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements\n* High-affinity TSPO-binding genotype. Mixed (high\u002Flow) binding-affinity genotype may be included at PIs discretion\n* For participants with severe asthma:\n\n  * Physician diagnosis of asthma for at least six months prior to screening (can be determined at the discretion of an asthma\u002Fallergy physician member of the study team)\n  * Severe asthmatics must meet the ATS definition of severe asthma and\u002For be currently receiving a GINA Step 4 or 5 therapy or daily treatment of 320mcg budesonide. Therapy may include ongoing use of currently approved biologic immunomodulators\n\nExclusion Criteria:\n\n* Current smoker (defined as more than 0.5 pack per week for the past 6 months and any smoking within two weeks of study procedures) or has a smoking history exceeding 5 pack years within the last 10 years\n* Currently receiving allergen immunotherapy unless on stable dose.\n* Use of psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI\u002FCo-I)\n* Inability to hold medications detailed in the medication hold schedule\n* Needle phobia or claustrophobia\n* Major health problems such any of the following in the last 6 months: stroke\u002FTIA, myocardial Infarction, stent placement, or acute coronary syndrome are definitively exclusionary. Decisions regarding other major health problems, such as autoimmune disease, history of carotid stenosis, heart disease, uncontrolled hypertension, lung diseases other than asthma, history of significant arrhythmias, etc. will be based upon the judgement of the PI\u002FCo-I.\n* Use of biologic medication that might affect signaling pathways under investigation (at the discretion of the PI\u002FCo-I)\n* Pre-existing chronic infectious disease\n* Scheduled use of non-selective beta-blockers prior to each study visit.\n* Use of an investigational drug within 30 days of entering the study. This criterion will be reviewed on a case by case basis by the PI\u002FCo-I to determine appropriate washout period. Appropriate wash out period may be greater than 30 days depending on the half-life of the investigational drug. Participants may be eligible for study participation after completing the washout period designated by the PI or Co-I (physician only).\n* Any MRI incompatibility as determined by most current MRI screening form\n* History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder\n* History of serious head trauma or seizure disorder (can be included at the discretion of the PI or Co-I)\n* Unable, in the judgement of the investigator, to comply with directions and\u002For tolerate the procedures required for participation in this study\n* Pregnant or breast-feeding or has a planned pregnancy during the course of the study\n* Any other medical condition or disease that would impact participant safety or data integrity in the opinion of the PI\u002FCO-I",{"count":517,"type":23},100,"The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:\n\n* How airway inflammation in asthma affects the brain; and,\n* Whether airway inflammation in asthma is related to symptoms of depression and anxiety\n\nOver the course of 3 visits, participants will:\n\n* Complete questionnaires\n* Complete computer tasks\n* Undergo allergy skin test and breathing tests\n* Give two blood samples\n* Give a sputum sample\n* Complete brain imaging scans\n\nResearchers will compare results between participants with asthma, and participants who do not have asthma.",[29],{"date":482,"type":36},{"date":522,"type":36},"2024-03-06",{"date":524,"type":23},"2028-08",{"name":526,"class":248},"University of Wisconsin, Madison",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100650339","phase-2-a-study-of-jnj-95597528-in-participants-with-inadequately-controlled-moderate-to-severe-asthma-100650339","NCT07746687","A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma","A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma","READY-BREATHE","Inclusion criteria:\n\n* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline\n* Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (\\>=) 200 milliliter (mL) and \\>=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) \\>=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after \\>=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by \\>=12% and \\>=200 mL, or increase in PEF by \\>=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: \\>=20% decrease from baseline in FEV1 with standard doses of methacholine, or \\>=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of \\>10% and \\>200 mL with standardized exercise challenge\n* Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose \\>=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose \\>=250 to 500 mcg fluticasone propionate or equivalent\n* Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist \\[LABA\\], long-acting muscarinic antagonist \\[LAMA\\] \\[can be combined with ICS in 1 inhaler or can be separate inhalers\\], leukotriene receptor antagonist \\[LTRA\\])\n* Asthma control questionnaire, 5-item (ACQ-5) score \\>=1.5 at the screening visit and the baseline visit\n\nExclusion criteria:\n\n* History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment\n* Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts\n* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling\n* Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma\n* Current smokers or former smokers with a smoking history \\>=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes","85 Years",{"count":420,"type":23},[26],"The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).",[29],"2026-07-31",{"date":482,"type":36},{"date":543,"type":23},"2026-09-23",{"date":545,"type":23},"2030-07-04",{"name":547,"class":43},"Janssen Research & Development, LLC",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":465},"100603297","implementation-of-a-joint-pulmonologist-and-ent-consultation-in-the-care-pathway-of-patients-suffering-from-asthma-and-chronic-rhinosinusitis-with-nasal-polyposis-effectiveness-compared-with-consultations-by-specialty-con-po-study-100603297","NCT07134686","Implementation of a Joint Pulmonologist and ENT Consultation in the Care Pathway of Patients Suffering From Asthma and Chronic Rhinosinusitis With Nasal Polyposis: Effectiveness Compared With Consultations by Specialty (CON-PO Study).","CON-PO","Inclusion Criteria:\n\n* Male or female, 18 years of age or older;\n* With a diagnosis of asthma;\n* With a diagnosis of chronic rhinosinusitis with nasal polyposis;\n* Whose asthma and\u002For chronic rhinosinusitis is\u002Fare not controlled according to SNOT-22 and ACQ-6 scores;\n* Having used systemic corticosteroids in the previous year to treat symptoms related to one of these conditions at least;\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of consent signature;\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (adult patients under guardianship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women);\n* Patients who do not read and\u002For understand French",{"count":556,"type":23},195,[558],"NA","Asthma affects the lower respiratory tract (bronchi), whereas chronic rhinosinusitis with nasal polyposis (CRSwNP) involves the upper airways. Despite this anatomical distinction, the upper and lower airways form a continuous respiratory tract and share common pathophysiological mechanisms. Consequently, asthma and CRSwNP frequently coexist, and several therapeutic strategies are effective for both conditions.\n\nGiven these overlaps, we hypothesize that a multidisciplinary consultation involving both a pulmonologist and an ENT specialist could be more effective than separate consultations for patient care. We also believe that this innovative organization that would benefit the healthcare system.\n\nTo test this hypothesis, we are conducting a study whose primary objective is to assess whether joint consultations lead to a reduction in oral corticosteroid need over the year following the initial consultation, by enabling more personalized treatment strategies.\n\nSecondary outcomes will include the frequency of asthma exacerbations, frequency of ENT-related events, respiratory symptoms, quality of life, and healthcare ressources utilization.\n\nWe will compare outcomes between two patient groups: one receiving joint consultation from both specialists, and the other managed through standard, separate consultations as per current clinical practice.",[29,400],[29,562,563],"Care pathway","Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)",{"date":565,"type":36},"2026-08-03",{"date":567,"type":36},"2026-07-28",{"date":569,"type":23},"2029-11",{"name":571,"class":248},"Assistance Publique Hopitaux De Marseille",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":24,"phases":582,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":465},"100644137","phase-4-betri-prospective-asthma-control-in-single-inhaler-icslabalama-8759-pmdi-bdpffgb---1006125-g-vs-single-inhaler-icslaba-2006-pmdi-bdpff---2006-g-100644137","NCT07666490","BETRI-Prospective: Asthma Control in Single Inhaler ICS\u002FLABA\u002FLAMA (87\u002F5\u002F9 pMDI [BDP\u002FFF\u002FGB - 100\u002F6\u002F12.5 μg]) vs Single Inhaler ICS\u002FLABA (200\u002F6 pMDI [BDP\u002FFF - 200\u002F6 μg])","A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS\u002FLABA\u002FLAMA (Beclometasone\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide [87\u002F5\u002F9 pMDI { BD\u002FFF\u002FGB -100\u002F6\u002F12.5 μg} ]) vs Single Inhaler ICS\u002FLABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200\u002F6 pMDI { BD\u002FFF - 200\u002F6 μg} ]) in Asthma Subjects","BETRI","Inclusion Criteria:\n\n1 . Study participant's written informed consent obtained prior to any study related procedure.\n\n2\\. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.\n\n4\\. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS\u002FLABA regular treatment.\n\n5\\. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).\n\n6\\. Women with childbearing potential (WOCBP) and with fertile male partners: they and\u002For their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.\n\n7\\. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.\n\nNote: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg\u002Fday of beclometasone or equivalent.\n\nExclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:\n\n1. Participation in another interventional clinical trial.\n2. Pregnant or breastfeeding women at the moment of enrolment.\n3. Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled\u002Fclinically significant diseases (according to investigator's judgement).\n4. Contraindication for LAMA use.\n5. Study participants on biological therapies for asthma.\n6. For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country\u002FRegion-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code.",{"count":581,"type":23},644,[500],"This study will evaluate the effect of triple ICS\u002FLAMA\u002FLABA therapy with a BDP\u002FFF\u002FGB 100\u002F6\u002F12.5 µg on asthma control outcomes relative to ICS\u002FLABA therapy with BDP\u002FFF 200\u002F6 μg in a population with asthma poorly controlled.",[29],[586,587,588,589,590],"asthma control","adults","pragmatic study","BDP\u002FFF\u002FGB","BDP\u002FFF","2026-07-30",{"date":540,"type":36},{"date":594,"type":36},"2026-06-28",{"date":596,"type":23},"2028-06-13",{"name":598,"class":43},"Chiesi Farmaceutici S.p.A.",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":24,"phases":607,"briefSummary":608,"conditions":609,"keywords":610,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":465},"100236070","structure-and-function-mri-of-asthma-100236070","NCT02351141","Structure and Function MRI of Asthma","Inclusion Criteria:\n\n* Subjects male and female aged 18-60 with a clinical diagnosis of asthma\n* Smoking history ≤ 1 pack\u002Fyear\n* Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent\n* Subject is judged to be in otherwise stable health on the basis of medical history\n* Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)\n* FEV1 \\>60% predicted\n\nExclusion Criteria:\n\n* Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material\n* Patient is unable to perform spirometry or plethysmography maneuvers\n* Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and\u002For ear implants.) (At the discretion of the MRI Technologist\u002F3T Manager)\n* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.\n* Patient is pregnant","60 Years",{"count":187,"type":23},[558],"The investigators will apply 129Xenon and\u002For 3He image acquisition and analysis methods in 200 asthma patient volunteers in order to characterize and probe the relationship between lung structure and function using imaging.",[29],[611,612,613],"Noble Gas MRI","Pulmonary Function","Quality of Life Questionnaires","2026-07-29",{"date":540,"type":36},{"date":617,"type":36},"2015-01",{"date":619,"type":23},"2030-12",{"name":621,"class":248},"Dr. Grace Parraga"]