[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-obstructive-pulmonary-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-obstructive-pulmonary-disease":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,118,0,25,[9,44,68,92,123,152,174,203,225,245,278,297,323,344,367,393,415,440,464,486,503,529,550,573,593],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100504144","phase-3-tadalafil-for-severe-pulmonary-hypertension-due-to-chronic-obstructive-pulmonary-disease-100504144",false,"NCT05844462","Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease","Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease","ERASE PH-COPD","Inclusion Criteria:\n\n* Patients ≥ 18 and \\\u003C85 years at inclusion,\n* Dyspnea WHO functional class II to IV,\n* Severe precapillary pulmonary hypertension defined by :\n\n  * a mean pulmonary artery pressure (mPAP) \\>20\n  * associated with normal pulmonary artery wedge pressure (PawP ≤15 mmHg)\n  * and pulmonary vascular resistance (PVR) \\>5 WU\n* COPD diagnosed according to current international recommendation with persistent airflow limitation defined by post-bronchodilatator Forced expiratory volume in 1 second (FEV1) \u002F forced vital capacity (FVC): FEV1\u002FFVC \\\u003C 0.70,\n* Naive patients from PDE5i (sildenafil, tadalafil) PH treatments and who did not receive other specific PH treatment in the last 3 months (bosentan, ambrisentan, macitentan, riociguat, epoprostenol, treprostinil, iloprost),\n* Treatments for COPD need to be stable for at least 1 month before screening visit,\n* Patients who fulfill criteria for a supplemental long-term oxygen therapy need to be supplied sufficiently before study entry. The amount of supplemental oxygen and the delivery method need to be stable for at least 1 month before screening visit,\n* Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period,\n* Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures,\n* Affiliation to a social security regime,\n\nExclusion Criteria:\n\n* Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,\n* Patients with underlying medical disorders and anticipated life expectancy below 12 months (eg active cancer disease with localized and\u002For metastasized tumor mass),\n* PH not due to chronic respiratory diseases (group 1, 2, 4 or 5 of the clinical classification of PH),\n* Other respiratory diseases: interstitial lung disease, sarcoidosis, lymphangioleiomyomatosis, histiocytosis, or untreated severe sleep apnea disorders,\n* 6-minutes walk distance \\\u003C 50 m or patients unable to perform the 6-minutes walk test,\n* Exacerbation of the COPD requiring hospitalization in the last 8 weeks before screening,\n* COPD with mild (\\> 80% predicted value) or severe (FEV1 \\\u003C30% predicted value) airflow limitation,\n* Patients listed for lung transplantation at the time of inclusion,\n* Systolic left ventricular dysfunction with left ventricular ejection fraction \\\u003C40% on echocardiography,\n* Patient on AME (state medical aid),\n* Participation in another clinical trial during the preceding 3 months and during the study,\n* Pregnant women, or breast-feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or oral contraceptives, or intrauterine devices) and one month after the end of the study, WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal \\[defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\\],\n* Patient under guardianship or curatorship\n\nNon-inclusion criteria related to treatment by tadalafil:\n\n* Contraindication to tadalafil:\n\n  * Severe renal failure (creatinine clearance \\\u003C 30 mL\u002Fmin\u002F1,73 m2)\n  * Severe liver cirrhosis Child-Plugh C\n  * Severe systemic hypotension \\\u003C90\u002F50\n  * Recent myocardial infarction \\\u003C90 days\n  * Medical history of anterior ischemic optic neuropathy\n  * Hypersensitivity to tadalafil or any of the excipients\n* Concomitant use of potent CYP3A4 inhibitors or inducers, soluble guanylate cyclase stimulator (riociguat), other PDE5 inhibitors or nitrates or doxazosin\n* Cardiovascular diseases:\n\n  * Clinically significant aortic and mitral valve disease\n  * Pericardial constriction\n  * Restrictive or congestive cardiomyopathy\n  * Significant left ventricular dysfunction\n  * Life-threatening arrhythmias\n  * Symptomatic coronary artery disease\n  * Uncontrolled hypertension.\n  * Angulation of the penis, cavernosal fibrosis, Peyronie's disease or history of priapism\n* Pulmonary or upper respiratory infection requiring antibiotics, or pulmonary embolism in the last 4 weeks before screening\n* Participation in a respiratory rehabilitation program within the 4 weeks prior to screening or scheduled during the study period\n* Right heart failure necessitating catecholamine support within the 4 weeks prior to screening.","ALL","18 Years","85 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","ERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.",[29,30],"Pulmonary Hypertension","Chronic Obstructive Pulmonary Disease","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-20","ACTUAL",{"date":37,"type":35},"2024-02-01",{"date":39,"type":23},"2027-12",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":20,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100651628","dynamic-functional-imaging-phenotyping-and-disease-progression-risk-assessment-in-copd-using-dynamic-chest-radiography-a-multicenter-retrospective-study-100651628","NCT07762573","Dynamic Functional Imaging Phenotyping and Disease Progression Risk Assessment in COPD Using Dynamic Chest Radiography: A Multicenter Retrospective Study","Inclusion Criteria:\n\n1. Aged 30-85 years.\n2. Male or female.\n3. Patients who underwent pulmonary function testing and dynamic chest radiography at the hospital.\n\nExclusion Criteria:\n\n1. Incomplete medical records.\n2. Considered unsuitable for inclusion in the study at the investigator's discretion.","30 Years",{"count":52,"type":23},2500,"OBSERVATIONAL","To evaluate the utility of DCR-derived parameters for identifying dynamic functional imaging phenotypes, assessing disease severity, and predicting the risk of disease progression in COPD.",[30],[57,58],"Chronic obstructive pulmonary disease","Dynamic Chest Radiography","2026-08-09",{"date":61,"type":35},"2026-08-13",{"date":63,"type":35},"2026-08-03",{"date":65,"type":23},"2030-01-30",{"name":67,"class":42},"Nanfang Hospital, Southern Medical University",{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":24,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100562444","phase-1-a-study-to-test-the-safety-and-effects-of-inhaled-gdc-6988-in-participants-with-muco-obstructive-disease-100562444","NCT06603246","A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease","A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease","Inclusion Criteria:\n\n* Percent predicted FEV1 ≥ 40% by spirometry during screening\n* Ability to demonstrate correct use of the smart DPI at screening, in the investigator's judgment\n* On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study\n* Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment\n\nAdditional Inclusion Criteria for Participants in Part B\n\n* Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item\n* Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development\n* Availability of a representative blood sample for exploratory biomarker research and biomarker assay development\n\nAdditional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):\n\n\\- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator\n\nAdditional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4):\n\n* COPD defined as post-bronchodilator FEV1\u002FFVC ratio of \\\u003C0.7\n* Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening\n* Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes\u002Fday for 10 years) or non-smoker with at least one documented COPD risk factor\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required\n* Known significant bronchodilator response of \\>10% predicted change in FEV1 or FVC, in the investigator's judgment\n* Use of any prohibited medications\n* Acute respiratory infection within 28 days of screening\n* Significant hemoptysis greater than 60 milliliter (mL) within 3 months prior to screening\n* Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections.\n* Known substance abuse, in the investigator's judgment, within 12 months prior to screening\n* Poor peripheral venous access\n* Receipt of blood products within 120 days prior to screening\n* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results\n* History of thoracic or metastatic malignancy within 5 years prior to screening\n* Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator\n* QT interval corrected through use of Fridericia's formula (QTcF) \\>450 milliseconds (ms) for males or \\>470 ms for females\n\nAdditional Exclusion Criteria for Participants in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening\n\nAdditional Exclusion Criteria for Participants With NCFB (Cohort 1, Cohort 2, and Cohort 3)\n\n* Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment\n* Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings)\n* NCFB exacerbation within 28 days prior to screening or that has not returned to baseline\n* Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes.\n\nAdditional Exclusion Criteria for Participants with NCFB in Cohort 3\n\n\\- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings)\n\nAdditional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4):\n\n* COPD exacerbation within 28 days prior to screening or that has not returned to baseline\n* Asthma\u002FCOPD overlap syndrome",{"count":76,"type":23},128,[78],"PHASE1","This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.",[81,30],"Non-cystic Fibrosis Bronchiectasis",{"date":83,"type":35},"2026-08-04",{"date":85,"type":35},"2024-11-18",{"date":87,"type":23},"2027-11-15",{"name":89,"class":90},"Genentech, Inc.","INDUSTRY",7,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":24,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":91},"100598627","phase-4-a-study-to-investigate-the-effect-of-budesonideglycopyrroniumformoterol-fumarate-metered-dose-inhaler-bgf-mdi-compared-with-placebo-mdi-on-heart-and-lung-function-in-participants-with-chronic-obstructive-pulmonary-disease-copd-and-hyperinflation-100598627","NCT07073950","A Study to Investigate the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation","A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation","ORATOS","Key Inclusion Criteria:\n\n* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.\n* A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second\u002Fforced vital capacity (FEV1\u002FFVC) \\\u003C 0.7.\n* At Visit 1: A pre-bronchodilator FEV1 \\\u003C 80%.\n* At Visit 1: Peripheral blood eosinophil count \\\u003C 300 cells\u002Fcubic millimeter (mm³), with no recorded history of eosinophil count \\> 300 cells\u002Fmm³ in the past 12 months.\n* At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.\n* At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \\> 135% of predicted normal FRC.\n* At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of the predicted normal value.\n* Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.\n* Female participants must either be not of childbearing potential or using a form of highly effective birth control.\n* All women of child bearing potential must have a negative pregnancy test at the Visit 1.\n\nExclusion Criteria:\n\n* A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.\n* History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.\n* History of myocardial infarction or acute coronary syndrome.\n* History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).\n* Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.\n* Participants with ECG QTcF interval at Visit 1 \\> 460 milliseconds (ms) for males and \\> 480 ms for females.\n* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and\u002For during the screening\u002Frun-in period.\n* Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.","40 Years","80 Years",{"count":103,"type":23},56,[105],"PHASE4","The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.",[30,108],"Hyperinflation",[110,111,112,113],"Metered Dose Inhalers (MDI)","Inhaled Corticosteroid (ICS)","Long-acting muscarinic antagonist (LAMA)","Long-acting beta2 agonist (LABA)","2026-07-23",{"date":116,"type":35},"2026-07-24",{"date":118,"type":35},"2025-11-24",{"date":120,"type":23},"2027-05-31",{"name":122,"class":90},"AstraZeneca",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":130,"targetDuration":4,"studyType":24,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":43},"100632361","titrated-ambulatory-oxygen-in-fibrotic-ild-and-copd-with-isolated-exertional-hypoxemia-100632361","NCT07512687","Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia","Impact of Ambulatory Oxygen Delivery on Real-world Activity and Quality-of-life in Patients With Interstitial Lung Disease (ILD) and Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n* Adults \\>= 18 years old and \\\u003C= 85 years old with fibrotic ILD or COPD able to provide informed consent\n* Fibrotic ILD includes idiopathic pulmonary fibrosis, sarcoidosis, or other ILD with fibrotic changes on lung imaging (reticulations, honeycombing, traction bronchiectasis)\n* COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease (GOLD) diagnostic criteria\n* Participants will self-report as being ambulatory outside of home without use of assistance device such as a cane or walker\n* Stable lung disease on stable medical therapy for preceding 3 months\n* Isolated exertional hypoxemia (SpO2 less than 89% for \\>=10 seconds) on a 6MWT conducted while breathing room air\n* Able to maintain SpO2 \\>=89% for the full duration of a 6MWT while using the the POC and portable oxygen D-tank at POC setting of no higher than 6 and D-tank flow rate no higher than 6 liters per minute\n\nExclusion Criteria:\n\n* People \\\u003C18 years old or \\>85 years old\n* Participants with mixed ILD and COPD diagnoses\n* Resting hypoxemia less than 89% while breathing room air\n* Emergency room visit or hospital admission in 3 months prior to recruitment\n* Change in medical therapy in 3 months prior to recruitment\n* Need for ambulatory assistive device such as cane or walker\n* Pregnant\n* Currently smoking or residing with a current smoker\n* Currently engaged in a pulmonary rehabilitation program\n* Participants without a smartphone compatible with the Oxiwear app (necessary to collect Oxiwear oxygen saturation data) or those with a compatible smartphone but without home wifi or cellular service plan allowing for Oxiwear data uploading",{"count":131,"type":23},24,[133],"NA","Fibrotic forms of interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are chronic lung disease which often affect how well oxygen can get from the lungs into the blood. Low blood oxygen levels often leads to shortness of breath which can affect patients' activity levels and quality-of-life. Many people with fibrotic ILD and COPD only have low oxygen levels when they are walking or exercising. Oxygen that is only used for walking or exercise is called ambulatory oxygen therapy (AOT). Laboratory studies suggest that AOT improves shortness of breath and exercise ability. However, real-world studies of AOT have not shown similar results. AOT can be given to patients through different types of equipment, most commonly oxygen tanks or portable oxygen concentrators (POCs). While previous studies have suggested that AOT does not significantly improve patients' breathing or activity in the real-world, these studies most often gave all participants the same amount of oxygen with the same device. However, patients with ILD and COPD often have very different oxygen needs during exercise, and POCs and oxygen tanks are very different in how oxygen is administered.\n\nThis trial will test the feasibility of a study to determine whether real-world activity, symptoms, and quality-of-life are different with the use of different oxygen equipment when oxygen therapy has been adjusted to meet each participants' oxygen needs. A total of 24 participants (12 with fibrotic ILD and 12 with COPD) who only have low oxygen levels with activity will be randomly assigned to 2-week periods using either no oxygen therapy or oxygen delivered by oxygen tanks or POC. This trial will provide preliminary data to support a larger clinical trial to further test how different AOT equipment titrated to meet individual patients' needs may affect real-world outcomes in people with ILD and COPD.",[136,30,137],"Interstitial Lung Disease","Hypoxemia",[139,140,141,142,143],"Ambulatory Oxygen Therapy","Portable Oxygen Concentrator","Exertional Hypoxemia","6-Minute Walk Test","Real-World Activity","2026-07-22",{"date":114,"type":35},{"date":147,"type":23},"2026-09-01",{"date":149,"type":23},"2027-10",{"name":151,"class":42},"State University of New York at Buffalo",{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100582353","this-is-a-non-interventional-study-to-assess-demographic-characteristics-and-patient-reported-outcomes-in-china-patients-with-sea-treated-with-benralizumab-100582353","NCT06862206","This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab","A Multicentre, Single Arm, Non-interventional, Prospective Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China","SPEED","Inclusion criteria -Patients are eligible to be included in the study only if all of the following criteria apply:\n\n* Patients must to be 12 years old (inclusive) at the time of signing the informed consent.\n* Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.\n* Blood EOS≥150\u002Ful in the 3 months prior to or EOS≥300\u002Ful in the 1 year prior to the time of signing the informed consent.\n* Participating patients and\u002For their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.\n\nExclusion criteria\n\n-Patients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n* Patients currently participating in any other clinical trial.\n* Known history of allergy or reaction to any component of the study treatment formulation.\n* Malignancy of any kind.\n* Patients with prior or ongoing treatment with benralizumab.",{"count":161,"type":23},1000,"The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.",[30],[165],"COPD","2026-07-21",{"date":144,"type":35},{"date":169,"type":35},"2025-07-11",{"date":171,"type":23},"2028-01-30",{"name":122,"class":90},36,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":24,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100636477","phase-3-long-term-safety-and-tolerability-of-tozorakimab-in-patients-with-copd-and-history-of-exacerbations-100636477","NCT07566195","Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations","A Phase III, Multicentre, Open-Label, Chronic Dosing, Extension Study to Evaluate the Long-term Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (ROMEO)","ROMEO","Inclusion Criteria:\n\n1. Participants previously randomized in predecessor studies.\n2. Participants should be affiliated with the French Social Security system.\n3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.\n4. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Clinically important pulmonary disease other than COPD.\n2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.\n3. Current alcohol, drug or chemical abuse.\n4. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.\n5. Known history of:\n\n   1. Severe allergic reaction to any monoclonal and polyclonal antibody.\n   2. Allergy or reaction to any component of the IMP formulation.\n6. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.\n7. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.\n8. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.\n9. Chronic use of antibiotics if the duration of treatment is \\\u003C 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose\u002Fregimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy.\n10. Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1.\n11. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).\n12. Participation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer.\n13. Involvement in the planning and\u002For conduct of the study (applies to both staff employed by the Sponsor and\u002For staff at the study site).\n14. Participants who are not able to comply with the study requirements, procedures, and restrictions.","99 Years",{"count":184,"type":23},59,[26],"ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations.\n\nEligible participants must have completed one of the predecessor studies.",[30,165],[189,190,30,165,191,192,193,194],"Tozorakimab","MEDI3506","Exacerbations","Safety","Biologic","Biologic Treatment","2026-07-20",{"date":166,"type":35},{"date":198,"type":35},"2026-05-05",{"date":200,"type":23},"2028-12-29",{"name":122,"class":90},13,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100546085","functional-improvement-in-osa-and-copd-with-a-telehealth-lifestyle-and-exercise-intervention-100546085","NCT06390345","Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention","FOCuSEd","Inclusion Criteria:\n\n* COPD: Defined by presence of airflow obstruction (FEV1\u002FFVC \\\u003C 0.70) on post-bronchodilator spirometry\n* ≥10 pack year history of tobacco use\n* Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)\n* BMI ≥ 25 kg\u002Fm2\n* Symptoms of dyspnea defined by MMRC score of ≥1\n\nExclusion Criteria:\n\n* Self-report of weight change \\>15 lbs. during prior 3 months\n* Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.\n* Severe illness from any cause\n* Diagnosis of bulimia or history of purging behavior\n* Active enrollment in pulmonary rehabilitation\n* Safety and\u002For adherence concerns due to severe physical or mental health issues or life expectancy \\\u003C 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Participation in other intervention studies.\n* Prisoner\n* Unable to complete surveys in English",{"count":211,"type":23},400,[133],"The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or \"enhanced\" usual care, stratifying by age (≥65 vs. \\\u003C 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the \"enhanced\" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.",[30,215,216],"Obstructive Sleep Apnea","Overweight and Obesity",{"date":144,"type":35},{"date":219,"type":35},"2024-07-29",{"date":221,"type":23},"2028-10-01",{"name":223,"class":42},"Seattle Institute for Biomedical and Clinical Research",5,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":244},"100541800","phase-4-molecular-signatures-associated-with-response-to-ics-treatment-in-patients-with-copd-stratified-by-eosinophil-levels-100541800","NCT06334575","Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels","3TR-ICS-COPD","Inclusion Criteria:\n\n* Male and female patients ≥40 years of age.\n* ≥ 10 pack-years smoking.\n* Former smokers (≥6 months).\n* post-bronchodilator FEV1\u002FFVC\\\u003C0.70.\n* FEV1 ≥30 (i.e. mild-moderated COPD patients).\n* Signed written informed consent form.\n* On regular treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage.\n* Women of child-bearing potential\\* must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n* Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.\n\nExclusion Criteria:\n\n* Presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (\\\u003C21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia).\n* Long-term oxygen therapy or non-invasive mechanical ventilation at home.\n* Current smokers.\n* Active cancer.\n* Use of ICS in the 3 months prior to the recruitment.\n* Participating in another randomized trial.\n* Not likely to complete the study.\n* Pregnant or breastfeeding females.\n* Exacerbations in the previous 8 weeks.\n* Primary or secondary immunodeficiency.\n* Immunosuppression or regular oral corticosteroid treatment.\n* Allergy to IMP's excipients.\n* Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.",{"count":233,"type":23},135,[105],"The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or \\> 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome",[30],"2026-07-17",{"date":195,"type":35},{"date":240,"type":35},"2025-02-12",{"date":39,"type":23},{"name":243,"class":42},"Maria Joyera Rodríguez",6,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":43},"100443973","phase-2-oral-sildenafil-for-exercise-capacity-dyspnea-and-cardiopulmonary-function-in-copd-100443973","NCT05061368","Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD","The Effect of Oral Sildenafil on Exercise Capacity, Dyspnea and Cardiopulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\nParticipants will have COPD as defined as:\n\n1. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1\u002FFVC) below the lower limit of normal\n2. FEV1 \\>30% of predicted (lower limit of GOLD severe COPD classification)\n\nCOPD Free Controls will have:\n\n1. No diagnosis of COPD\n2. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1\u002FFVC) above the lower limit of normal\n3. FEV1 \\>80% of predicted\n\nExclusion Criteria:\n\n1. Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.\n2. Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing\n3. A diagnosis of pulmonary hypertension preceding COPD\n4. Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use.\n5. Pregnancy or lactation.\n6. Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, female condom, male condom). Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active.\n7. Postmenopausal female participants must be amenorrheic for ≥12 months.",true,{"count":254,"type":23},160,[256],"PHASE2","Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction.\n\nMild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E\u002FV̇CO2). Recent work suggests that the increased V̇E\u002FV̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and\u002For ventilation\u002Fperfusion (V̇A\u002FQ) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A\u002FQ inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries.\n\nRecently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E\u002FV̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.",[30],[165,260,261,262,263,264,265,266,267,268],"Sildenafil","Pulmonary Vascular Function","Pulmonary Vascular Pressure","DLCO","Pulmonary Capillary Blood Volume","Dyspnea","Exercise Tolerance","Peak Oxygen Uptake","Cardiopulmonary Fitness","2026-07-07",{"date":271,"type":35},"2026-07-08",{"date":273,"type":35},"2022-03-01",{"date":275,"type":23},"2027-05",{"name":277,"class":42},"University of Alberta",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":252,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":285,"targetDuration":4,"studyType":24,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":4},"100380297","phase-1-the-effect-of-inhaled-nitric-oxide-on-pulmonary-gas-exchange-in-copd-100380297","NCT04231760","The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD","iNO","Inclusion Criteria:\n\n* Twenty participants with mild COPD (forced expiratory volume in 1 s (FEV1)\u002Fforced vital capacity (FVC) below the lower limit of normal (\\\u003C-1.64 z-score)1) and FEV1 ≥ 80% predicted, with a smoking history (10 \\> pack-years) will be recruited. Twenty participants with moderate COPD (FEV1\u002F FVC below the lower limit of normal (\\\u003C-1.64 z-score)1) and FEV1 50-80% predicted, with a smoking history (10 \\> pack-years) will also be recruited. Additionally, 40 healthy individuals with be recruited.\n* Participants will be free of any known significant cardiovascular, metabolic or neuromuscular disease. Participants with COPD will have global initiative for chronic obstructive lung disease (GOLD) Stage 1 mild COPD (FEV1\u002FFVC ratio \\\u003C0.70 and FEV1 ≥ 80% predicted1) and Stage 2 moderate COPD (FEV1\u002FFVC ratio \\\u003C0.70 and FEV1 50-80% predicted) and a \\>10 pack-year smoking history. Controls will have normal lung function, minimal smoking history and no previous diagnosis of COPD. Participants will range from 18-85 years old.\n\nExclusion Criteria:\n\n* Individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded.\n* Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials will be excluded.\n* COPD participants currently on oral steroids (i.e. prednisone), phosphodiesterase type 5 (PDE5) inhibitors or supplemental O2 therapy will be excluded.",{"count":286,"type":23},80,[78,256],"Chronic Obstructive Pulmonary Disease (COPD) is a lung disorder commonly caused by smoking, which makes breathing more difficult. When COPD patients exercise, they are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. Even though patients with a mild form of COPD have relatively well preserved lung function, they still have inefficient breathing during exercise. The investigators think that these individuals have problems exchanging fresh gas (i.e., oxygen) into the blood stream because of poor lung blood vessel function. The investigators will test whether inhaled medications, specifically nitric oxide, can improve lung blood vessel function and decrease breathing difficulties during exercise. With this research, the investigators will understand more about breathing efficiency and lung blood vessel function in individuals with mild COPD, and find out whether improving lung blood vessel function helps COPD patients breathe easier and exercise longer. Understanding the reasons behind the feeling of difficult breathing may lead to more effective therapy and improved quality of life in COPD patients.",[30],"NOT_YET_RECRUITING",{"date":271,"type":35},{"date":293,"type":23},"2026-12-01",{"date":295,"type":23},"2028-02-01",{"name":277,"class":42},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":252,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"100629403","expression-of-slc25a48-in-chronic-obstructive-pulmonary-disease-100629403","NCT07474220","Expression of SLC25A48 in Chronic Obstructive Pulmonary Disease","Association Between SLC25A48 Expression and Chronic Obstructive Pulmonary Disease Progression","Inclusion Criteria:\n\n* pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines (case group)\n* healthy individuals without chronic diseases or major medical conditions\n\nExclusion Criteria:\n\n* diagnosed with neuromuscular diseases\n* experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months\n* assessed by a physician to have severe malnutrition or a significantly low BMI\n* continuously taking folic acid supplements\n* willing to receive or have already received self-paid nutrition clinic services at this hospital",{"count":305,"type":23},180,"This study aims to investigate the expression level of SLC25A48, a mitochondrial choline transporter, in peripheral blood mononuclear cells of patients with chronic obstructive pulmonary disease, and to analyze its correlation with inflammatory markers and choline metabolic byproducts.",[30],[57,309,310,311,312],"Mitochondrial choline transport","SLC25A48","Inflammatory markers","Choline metabolism","2026-07-01",{"date":315,"type":35},"2026-07-06",{"date":317,"type":35},"2026-06-29",{"date":319,"type":23},"2026-12-31",{"name":321,"class":42},"Fu Jen Catholic University",2,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":252,"sex":18,"minAge":19,"maxAge":101,"enrollmentInfo":330,"targetDuration":4,"studyType":24,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100588709","phase-1-a-study-of-bbt002-in-healthy-volunteers-hvs-and-in-adult-patients-with-chronic-obstructive-pulmonary-disease-copd-or-chronic-rhiosininusitis-with-nasal-polyps-crswnp-100588709","NCT06944925","A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)","A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients With COPD or CRSwNP","Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)\n\n1. Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)\n2. Body mass index between 18.0-32.0 kg\u002Fm square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg\u002Fm square, capped weight at 125kg for patients (Parts C, D, F, and G)\n3. Negative pregnancy tests for women of childbearing potential\n4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit\n5. Non-smokers, healthy current smokers (≤5 cigarettes\u002Fday), or ex-smokers\n6. Adequate contraception use (for men and women of childbearing potential)\n7. No clinically significant abnormalities or history of relevant diseases\n\nKey Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second\u002FForced Vital Capacity less than 0.70\n\nKey Inclusion Criteria (Parts D and G)\n\n1\\. Participants with confirmed diagnosis of CRSwNP\n\nKey Exclusion Criteria for (Parts A, B, C, D, E, F, and G)\n\n1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)\n2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections\n3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders\n4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function\n5. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1\n6. Abnormal Electrocardiogram(ECG) findings\n7. History of drug\u002Falcohol abuse in the past 2 years\n8. History of severe allergic reactions or hypersensitivity\n\nKey Exclusion Criteria (Part C and F only)\n\n1. Current diagnosis of other significant pulmonary disease\n2. Significant or unstable cardiovascular diseases\n3. Recent clinically significant infection\n4. Inability to perform spirometry\n\nKey Exclusion Criteria (Parts D and G)\n\n1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP\n2. Sinonasal surgery (recent\u002Fextensiv)\n3. Consitions interfering with nasal assessments\n4. Excluded sinonasal\u002Fsystemic diseases",{"count":331,"type":23},286,[78],"Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).",[30],"2026-06-28",{"date":313,"type":35},{"date":338,"type":35},"2025-05-08",{"date":340,"type":23},"2027-07-31",{"name":342,"class":90},"Bambusa Therapeutics",14,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":101,"enrollmentInfo":352,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":173},"100598310","study-of-clinical-and-patient-reported-outcomes-in-adults-with-moderate-to-severe-copd-treated-with-breztritrixeo-100598310","NCT07069829","Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo","Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo in Routine Care Settings","iCHOROS","Inclusion Criteria:\n\nThe study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:\n\n1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.\n2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.\n3. Patients providing a written Informed Consent\\* prior to inclusion to the study.\n\n   \\*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.\n4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be eligible to participate in the study:\n\n1. Patients with COPD due to documented α-1 antitrypsin deficiency.\n2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).\n3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.\n4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.\n5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.\n6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.\n7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.\n8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.",{"count":353,"type":23},1400,"Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI\u002FTRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life.\n\nThe iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \\& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations",[30],[165,357,358,359],"Moderate to Severe Chronic Obstructive Pulmonary Disease","Severe Exacerbations","BGF - Budesonide\u002FGlycopyrrolate\u002FFormoterol Fumarate","2026-06-26",{"date":317,"type":35},{"date":363,"type":35},"2025-12-15",{"date":365,"type":23},"2027-09-30",{"name":122,"class":90},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":43},"100535529","charm-copd-program-of-care-100535529","NCT06253013","CHARM-COPD Program of Care","A Program of Care in Chronic Obstructive Pulmonary Disease Involving Virtual Pulmonary Rehabilitation, Integrated Care and Remote Clinical Monitoring After Discharge From a Recent Exacerbation: Mixed-Methods Study on Feasibility","Inclusion Criteria:\n\n* Referred to either Virtual Pulmonary Rehabilitation or Remote Clinical Monitoring at Toronto Grace Health Centre after discharge from UHN hospital with an AECOPD as defined by the clinical team\n\nExclusion Criteria:\n\n* Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma\n* Projected life expectancy ≤ 2 months , as determined by the clinical team\n* Significant cognitive impairment and absence\u002Finability of a family caregiver to consent and to follow study processes",{"count":375,"type":23},100,[133],"The investigators' goal for this project is to evaluate the feasibility, acceptability, and actual usage of a program of care for patients with COPD recently discharged after an acute exacerbation. The program of care includes virtual pulmonary rehabilitation, integrated care, and remote clinical monitoring.",[30],[380,165,381,382,383],"Remote Clinical Monitoring","Wearables","Digital Health","Self-management","2026-06-17",{"date":386,"type":35},"2026-06-22",{"date":388,"type":35},"2023-09-15",{"date":390,"type":23},"2027-06",{"name":392,"class":42},"University Health Network, Toronto",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":43},"100472846","study-of-microbiological-diversity-in-exhaled-air-in-copd-and-free-of-copd-100472846","NCT05437198","Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD","Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD","EXHALBIO","Inclusion Criteria:\n\nFor COPD:\n\n* Patients with chronic obstructive pulmonary disease\n* Age: over 18\n\nFor non-COPD\n\n* Absence of chronic obstructive pulmonary disease\n* Age: between 18 and 30 years old and between 45 and 70 years old\n\nExclusion Criteria:\n\n* Taking certain medications in the month preceding the sample (antibiotics, systemic corticosteroids, immunosuppressants)\n* Person under guardianship or curatorship\n* Pregnant or breastfeeding women\n* Person unable to express his\u002Fher opposition, person deprived of liberty\n* Existence of a chronic infectious pulmonary pathology such as (dilation of the bronchi, cystic fibrosis)","70 Years",{"count":403,"type":23},240,"COPD and non-COPD patients will be included in the study after collection of their non-objection. The exhalation will be collected to study the microbiological diversity of human exhalations.\n\na second collection for the year +1 will be made, at the same time (between October and March).",[30],"2026-06-15",{"date":408,"type":35},"2026-06-16",{"date":410,"type":35},"2024-03-26",{"date":412,"type":23},"2029-03",{"name":414,"class":42},"Centre Hospitalier Intercommunal Creteil",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":43},"100466247","thermotherapy-against-persistent-bacterial-lung-infections-100466247","NCT05351242","THERMotherapy Against Persistent Bacterial LUNG Infections","Thermotherapy Against Persistent Bacterial LUNG Infections","THERMA-LUNG","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Competent and capable\n* FEV1\\>1,0 L\n* Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics\n* Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months\n\nExclusion Criteria:\n\n* Allergy to lidocaine and\u002For midazolam\n* Contraindications to bronchoscopy\n* Previous severe laryngospasm (intubation requiring)\n* Pregnancy\u002Fbreastfeeding\n* Severe linguistic problems or inability to give informed consent\n* Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others",{"count":424,"type":23},150,[133],"The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.",[428,429,430,431,30,432],"Lung Diseases, Obstructive","Bronchiectasis","Asthma","Copd","Chronic Lung Infections",{"date":384,"type":35},{"date":435,"type":23},"2026-10-01",{"date":437,"type":23},"2029-12-31",{"name":439,"class":42},"Chronic Obstructive Pulmonary Disease Trial Network, Denmark",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100641086","a-personalized-mobile-application-providing-temperature-related-health-risk-warnings-and-protective-recommendations-for-patients-with-chronic-obstructive-pulmonary-disease-100641086","NCT07656142","A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease","Effectiveness of A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease","Hospital inclusion criteria:\n\n1. Tertiary hospitals;\n2. Hospitals with respiratory wards that admit patients with COPD;\n3. Hospitals with a well-established electronic health record system and follow-up capability;\n4. Hospitals able to assign a study coordinator.\n\nPatient inclusion criteria:\n\n1. Age \\>=40 years and \\\u003C=80 years, with no restriction on sex;\n2. Patients with stable chronic obstructive pulmonary disease;\n3. At least 1 severe acute exacerbation requiring hospitalization, or at least 2 moderate acute exacerbations requiring outpatient or emergency care, within the previous year;\n4. Local permanent residents with a duration of residence \\>=6 months;\n5. Patients who voluntarily agree to participate, are expected to have good adherence, are able to sign informed consent;\n6. Patients who own a smartphone or other smart device.\n\nHospital exclusion criteria:\n\n1. Primary hospitals or private hospitals;\n2. Hospitals unable to cooperate with the study protocol.\n\nPatient exclusion criteria:\n\n1. Patients with asthma;\n2. Women who are known to be pregnant or breastfeeding, or who have a positive pregnancy test before cluster randomization;\n3. Patients with other diseases that may affect participation in the trial, such as refractory hypertension or severe aphasia;\n4. Patients currently receiving psychiatric or psychological treatment that may contaminate study results;\n5. Expected survival time \\\u003C1 year, such as in those with malignant tumors or severe cardiopulmonary disease;\n6. Participation in other interventional clinical studies that may affect outcome assessment;\n7. Any other circumstances in which the investigator considers the patient unsuitable for participation in this study or at significant risk, such as cognitive impairment preventing understanding of and\u002For compliance with study procedures and\u002For follow-up.",{"count":403,"type":23},[133],"This study will test whether a personalized mobile application that provides temperature-related health risk warnings and protective recommendations can reduce acute exacerbations in people with chronic obstructive pulmonary disease (COPD). Researchers will compare participants who receive the mobile application in addition to usual care with those who receive usual care alone. The main question is whether the mobile application reduces the number of COPD acute exacerbation events over 12 months. The study will also evaluate secondary outcomes including quality of life, functional capacity, symptoms, psychological status, physiological and biochemical indicators, environmental temperature risk perception, and participants' use of the mobile application.",[30],[165,452,453],"Temperature-related Health Risk","Mobile Application Intervention","2026-06-14",{"date":456,"type":35},"2026-06-18",{"date":458,"type":23},"2026-06",{"date":460,"type":23},"2027-08",{"name":462,"class":463},"Tiantian Li","OTHER_GOV",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":472,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100607566","phase-3-efficacy-safety-and-tolerability-study-of-lunsekimig-compared-with-placebo-in-adult-participants-with-inadequately-controlled-chronic-obstructive-pulmonary-disease-copd-characterized-by-an-eosinophilic-phenotype-100607566","NCT07190222","Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype","A Phase 2b\u002FPhase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype","THESEUS","Inclusion Criteria:\n\n* Between 40 to 80 years of age\n* Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year\n* Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1\u002FFVC (forced expiratory volume in 1 second \u002Fforced vital capacity) \\\u003C0.70\n* Former or current smokers ≥10 pack-years\n* Chronic Airways Assessment Test (CAAT) ≥10\n* ≥2 moderate or ≥1 severe COPD exacerbations in the prior year\n* Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks\n* EOS (blood eosinophil count) ≥ 150 cells\u002FμL\n* 18.0 ≤ Body Mass Index ≤ 40.0 kg\u002Fm2\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)\n* Significant pulmonary disease other than COPD\n* Long-term oxygen therapy \\>4.0 L\u002Fmin or requirement of \\>2.0 L\u002Fmin to maintain oxygen saturation \\>88% at rest\n* Unstable disorder that can impact participants safety or study outcomes\n* Active or incompletely treated tuberculosis\n* Current or past malignancies\n* Concomitant therapies:\n\n  * long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \\> 6 months\n  * any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":473,"type":23},942,[26],"This is a parallel, Phase 2b\u002FPhase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.\n\nParticipation to the study consists of 3 periods:\n\n* Screening period of up to 4 weeks\n* Randomized intervention period of approximately 48 weeks\n* Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.",[30],"2026-06-12",{"date":406,"type":35},{"date":480,"type":35},"2025-09-17",{"date":482,"type":23},"2030-01-22",{"name":484,"class":90},"Sanofi",213,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":494,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":475,"conditions":496,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":502},"100607565","phase-3-efficacy-safety-and-tolerability-study-of-lunsekimig-compared-with-placebo-in-adult-participants-with-inadequately-controlled-chronic-obstructive-pulmonary-disease-copd-characterized-by-an-eosinophilic-phenotype-100607565","NCT07190209","Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype","A Phase 2b\u002FPhase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype","PERSEPHONE","Inclusion Criteria:\n\n* Between 40 to 80 years of age\n* Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year\n* Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1\u002FFVC (forced expiratory volume in 1 second \u002Fforced vital capacity) \\\u003C0.70\n* Former or current smokers ≥10 pack-years\n* Chronic Airways Assessment Test (CAAT) ≥10\n* ≥2 moderate or ≥1 severe COPD exacerbations in the prior year\n* Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks\n* EOS (blood eosinophil count) ≥ 150 cells\u002FμL\n* 18.0 ≤ Body Mass Index ≤ 40.0 kg\u002Fm2\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)\n* Significant pulmonary disease other than COPD\n* Long-term oxygen therapy \\>4.0 L\u002Fmin or requirement of \\>2.0 L\u002Fmin to maintain oxygen saturation \\>88% at rest\n* Unstable disorder that can impact participants safety or study outcomes\n* Active or incompletely treated tuberculosis\n* Current or past malignancies\n* Concomitant therapies:\n\n  * long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \\>6 months\n  * any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial",{"count":473,"type":23},[26],[30],{"date":406,"type":35},{"date":499,"type":35},"2025-09-16",{"date":482,"type":23},{"name":484,"class":90},215,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":252,"sex":18,"minAge":19,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":322},"100496388","innate-immunity-in-copd-100496388","NCT05743582","Innate Immunity in COPD","Analysis of Innate Immune Competence in People With Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\nCOPD patients:\n\n* COPD patients aged 18-77 years who are GOLD Stage 1 or 2 or 3; for patients undergoing bronchoscopy already for a clinical reason.\n* COPD patients aged 18-77 years old who are GOLD Stage 1,2 or 3 for patients who are donating blood only.\n* COPD patients aged 18-69 years who are GOLD Stage 1 or 2 for patients undergoing bronchoscopy for research purposes.\n* COPD- Defined by radiological investigation of chest either chest X-ray or High-resolution CT scan in previous 12 months\n* Ability to provide informed consent\n\nHealthy volunteers:\n\n* Any healthy volunteer aged 18-77 years\n* Ability to provide informed consent\n\nExclusion Criteria:\n\nCOPD patients:\n\n* Individuals known to have active malignancy, immunosuppression, diabetes mellitus, chronic kidney disease or hepatic failure.\n* Individuals with a history of anaemia\n* Individuals who have donated \\>250 ml of blood for any reason within the last 6 months\n* Individuals who are pregnant or breast feeding.\n* Current participation in any other clinical trial, except those directly relating to this cohort and study.\n* Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks\n* Individuals who have received a vaccine in the past 2 weeks\n* Inability to communicate in English or convey willingness to participate.\n* For bronchoscopy - Any significant lung condition that would contra-indicate bronchoscopy including:\n\nactive acute lung infection (with the exception of asymptomatic pulmonary colonisation) or malignancy, significant coexisting interstitial lung disease or additional pulmonary diagnosis in addition to COPD.\n\nHealthy volunteers:\n\n* Individuals known to have active malignancy, immunosuppression, diabetes mellitus, chronic kidney disease or hepatic failure\n* Individuals with anaemia on the screening full blood count (FBC)\n* Individuals who donated \\>250 ml of blood for any reason within the last 6 months\n* Individuals who are pregnant or breast feeding\n* Current participation in any other clinical trial\n* Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks.\n* Individuals who have received a vaccine in the past 2 weeks\n* Chronic or acute respiratory disease.\n* Any chronic medical condition or receipt of regular prescription medication other than the oral contraceptive pill.\n* Inability to communicate in English or convey willingness to participate\n* For bronchoscopy - Any active lung condition including any lung infection or asthma Any significant abnormality on CXR that would contraindicate bronchoscopy FEV1 \\\u003C65% predicted (BTS Guidelines, 2001)","77 Years",{"count":512,"type":23},189,"Chronic Obstructive Pulmonary Disease (COPD) causes obstruction to airflow when breathing out. It is a leading cause of chronic lung disease, hospitalization and death. Smoking is the major cause of COPD but why some smokers develop COPD while others do not is poorly understood. A central feature of COPD is accumulation of inflammatory blood cells, macrophages and neutrophils, in the airway, leading to lung injury and airway damage. The small airways of many patients with COPD contain bacteria, which are absent in healthy smokers or non-smokers. These bacteria stimulate recruitment of neutrophils, macrophages and other inflammatory cells, further accelerating airway injury. The investigators and others have shown resident macrophages in the lung and inflammatory cells (neutrophils and macrophages) recruited from the blood, which normally clear bacteria, have reduced anti-bacterial capacity in COPD and that their altered function impairs the resolution of inflammation. The investigators now wish to test why these cells fail to clear bacteria focusing in particular on how they use molecules as food to generate energy, a process termed metabolism, since this is an important determinant of immune cell function. Comparison will be made between lung resident cells (obtained by performing bronchoscopy and washing a segment of lung to flush out immune cells) and those from the blood to determine if the alterations are specific to the lung. The investigators will identify alterations in responses to bacteria in relation to changes in metabolism . A major focus will be on how structures in the cell that normally are key for energy production (i.e. mitochondria) become dysfunctional and how this impacts responses to bacteria. The investigators will relate findings to the clinical features of COPD and to healthy non-smokers and smokers to separate smoking-related changes from COPD. The aim is to develop new approaches with which to treat and manage COPD.",[30],[516,517,518,519,520,521],"Alveolar macrophages","Peripheral blood mononuclear cells","Neutrophils","Bactericidal mechanisms","Immune cell metabolism","Epigenetics",{"date":408,"type":35},{"date":524,"type":35},"2023-05-11",{"date":526,"type":23},"2028-02-10",{"name":528,"class":42},"University of Edinburgh",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":20,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":549},"100597048","phase-4-a-study-to-investigate-airway-inflammation-with-dupilumab-subcutaneously-in-participants-aged-40-to-85-years-with-chronic-obstructive-pulmonary-disease-100597048","NCT07053423","A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.","AEOLUS","Inclusion Criteria:\n\nParticipants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening:\n\n* Current or former smokers with a smoking history of ≥10 pack-years\n* Moderate-to-severe COPD (post-BD FEV1\u002FFVC ratio \\\u003C0.70 and post-BD FEV1 % predicted \\>30% and ≤70%)\n* Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10\n* Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations\n* Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated\n* Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells\u002FμL at screening or with blood eosinophils ≥150 cells\u002FμL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells\u002FμL within the past year during stable state (non-exacerbation).\n* Mucus score cutoff of ≥3\n\nExclusion Criteria:\n\n* A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma\n* Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts\n* Treatment with oxygen \\>4.0 L\u002Fmin for ≥8 hours\u002Fday Respiratory tract infection within 4 weeks before screening, or during the screening period\n* Diagnosis of α-1 anti-trypsin deficiency\n* Any biologic therapy (including experimental treatments and dupilumab)\n* Participants on treatment with mucolytics unless on stable therapy for \\>6 months\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":538,"type":23},218,[105],"LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).\n\nStudy details include:\n\nThe study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.",[30],"2026-06-11",{"date":477,"type":35},{"date":545,"type":35},"2025-09-22",{"date":547,"type":23},"2029-02-02",{"name":484,"class":90},68,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":24,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":572},"100643323","phase-2-a-clinical-trial-comparing-tqc3927-inhaled-powder-with-glycopyrronium-bromide-and-formoterol-inhaled-aerosol-biovoping-lingchang-for-the-treatment-of-chronic-obstructive-pulmonary-disease-100643323","NCT07633314","A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease","A Multicenter, Randomized, Open-label, Active-controlled Phase II Clinical Trial to Explore the Efficacy and Safety of Different Doses of TQC3927 Inhaled Powder in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Sign an informed consent form before the trial to fully understand the purpose, procedure, and possible adverse reactions;\n* Age: 40 years ≤ age ≤ 75 years (calculated from the date of signing the informed consent form), gender not limited;\n* Participants' body mass index (BMI) is within the range of 18\\~30 kg\u002Fm2 (including the borderline), and their weight is ≥45kg;\n* Diagnosed with Chronic Obstructive Lung Disease (COPD) according to the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, and symptoms consistent with COPD for at least 1 year before the screening visit (V1);\n* Participants must have discontinued short-acting β2-adrenergic receptor agonist (SABA) for at least 6 hours and short-acting cholinergic receptor antagonist (SAMA) for at least 8 hours before starting any pulmonary function tests;\n* Participants must be current or former smokers with a smoking history of ≥10 pack-years (pack-year: number of packs per day × number of years of smoking, such as 1 pack of 20 cigarettes per day for 10 consecutive years, or 10 cigarettes per day for 20 consecutive years); former smokers are defined as those who have quit smoking for at least 6 months prior to Visit 1. Note: Use of pipes, cigars, and e-cigarettes cannot be used to calculate packs\u002Fyear;\n* Trained participants are able to perform acceptable and reproducible pulmonary function tests according to American Thoracic Society\u002FEuropean Respiratory Society (ATS\u002FERS) 2005 criteria;\n* Participants voluntarily sign informed consent forms and have no plans for pregnancy within 90 days from the start of treatment to the last dose, and voluntarily use medically approved contraception (including with their partners);\n* Trained participants are able to correctly use a pressure metered-dose inhaler (pMDI), dry powder inhaler (DPI) inhaler for drug administration;\n* Participants are able to attend study visits on time and complete the visit content;\n\nExclusion Criteria:\n\n* Participants currently diagnosed with asthma (including asthma with COPD) or with a history of asthma, based on the investigator's judgment;\n* Participants with a current life-threatening COPD history;\n* Participants with concurrent active or clinically significant respiratory illnesses that significantly impact the study;\n* Participants with serious illnesses other than COPD, or abnormalities in laboratory tests, electrocardiograms, medical history, or physical examinations;\n* Participants who have undergone lung volume reduction surgery, lobectomy\u002Fsegmentectomy, or are expected to undergo lung surgery during the study period within 12 months prior to V1;\n* Participants who have developed pneumonia or lower respiratory tract infections requiring antibiotic treatment within 8 weeks prior to V1 or between V1 and V3;\n* Participants with clinically significant abnormalities on chest computed tomography (CT);\n* Participants currently using positive pressure ventilation;\n* Participants requiring long-term oxygen therapy (oxygen therapy time \\> 15 minutes). 10. Individuals undergoing pulmonary rehabilitation;\n* Participants who changed their smoking status (i.e., started or stopped smoking) or began a smoking cessation program within 6 weeks prior to screening;\n* Individuals with unstable or life-threatening heart disease;\n* Individuals using non-selective oral beta-blockers;\n* Individuals with unstable or uncontrolled hypertension;\n* Abnormal values in clinically significant safety laboratory tests determined by the investigator at the screening visit;\n* Positive results for human immunodeficiency virus (HIV); positive results for hepatitis B surface antigen (HBsAg); positive results for hepatitis C virus (HCV) antibody and supporting documentation.\n* Individuals with a confirmed history of neurological or psychiatric disorders, including epilepsy or dementia requiring treatment;\n* Individuals with a history or current condition of neuropsychiatric, respiratory, cardiovascular, digestive, hematopoietic, lymphatic, immune, hepatic or renal insufficiency, endocrine, musculoskeletal, or other diseases;\n* Individuals who have participated in any drug or medical device clinical trial and received a study intervention within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening;\n* Individuals who have lost or donated more than 400 ml of blood within 3 months prior to the trial. 21. Individuals with a known history of drug or food allergies, especially to components similar to the investigational drug;\n* Individuals who have frequently consumed alcohol within the 6 months prior to screening, or who have tested positive for alcohol in a breathalyzer test;\n* Individuals who have received a live attenuated vaccine within 28 days prior to randomization, an inactivated vaccine within 7 days prior to randomization, or are scheduled to receive a vaccine during the study period;\n* Individuals with a history of any organ or systemic malignancy within the past 5 years;\n* Individuals with a history of drug abuse within the past 2 years, or who have tested positive for drug abuse;\n* Individuals assessed by the investigators as unable to discontinue prohibited drugs as specified in the protocol during the screening and treatment phases of this study;\n* Pregnant or lactating women, or female participants with positive pregnancy test results;\n* Individuals with difficulty obtaining venous blood or a history of fainting from needles or blood loss;","75 Years",{"count":559,"type":23},90,[256],"This is a multicenter, randomized, open-label, positive-drug controlled study designed to evaluate the preliminary efficacy and safety of different doses of TQC3927 inhaled powder for short-term treatment of patients with chronic obstructive pulmonary disease, and to observe the symptoms and pharmacokinetic (PK) characteristics of participants.",[30],"2026-06-03",{"date":565,"type":35},"2026-06-08",{"date":567,"type":23},"2026-07",{"date":569,"type":23},"2027-01",{"name":571,"class":90},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",15,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":580,"targetDuration":4,"studyType":24,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":43},"100619815","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-rss0343-tablets-in-patients-with-chronic-obstructive-pulmonary-disease-100619815","NCT07349524","A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease","Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Aged 40 to 80 years, male or female.\n3. Body mass index (BMI) ≥18 kg\u002Fm².\n4. Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.\n5. Post-bronchodilator FEV₁\u002FFVC \\\u003C0.7 at the screening period; and post-bronchodilator FEV₁\u002FFVC \\\u003C0.7 with FEV₁% predicted ≥20% at baseline.\n6. Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.\n7. On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.\n8. COPD Assessment Test (CAT) score ≥10 at screening and randomization.\n9. Current or former smoking history of ≥10 pack-years at screening.\n10. Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm\u002Fova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.\n\nExclusion Criteria:\n\n1. Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.\n2. Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.\n3. Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive\u002Fexpectorant medications, infusion of blood products or immunoglobulins.\n4. Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.\n5. Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.\n6. Participation in another clinical trial involving an investigational product with active ingredients within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening.\n7. Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.\n8. Lung surgery or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.\n9. Requirement for supplemental oxygen therapy for ≥15 hours per day or mechanical ventilation; or clinically significant sleep apnea requiring the use of a continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.\n10. Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.\n11. Coexisting other respiratory or respiratory-related diseases.\n12. Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.\n13. Presence of autoimmune diseases mediated by eosinophils at screening.\n14. Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.\n15. Diagnosis of psoriasis or lichen planus; Reiter's disease\u002Fkeratoderma blennorrhagicum, keratoderma hemorrhagicum, or reactive arthritis; systemic lupus erythematosus, atopic dermatitis, chronic hand dermatitis, chronic contact dermatitis, or chronic psoriasis; chloracne, extensive verruca vulgaris, or keratotic dermatitis.\n16. Known other severe medical conditions.\n17. Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria.\n18. Suspected or known hypersensitivity to the investigational product or any of its excipients.\n19. Blood donation or blood loss ≥200 mL within 1 month prior to randomization, or ≥400 mL within 3 months prior to the first dose; or receipt of a blood transfusion within 8 weeks prior to the first dose; or difficulty with venipuncture, or physical condition unsuitable for intensive blood sampling.\n20. Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period.\n21. History of drug abuse or substance abuse within 1 year prior to screening.\n22. Any other medical or social reason deemed by the investigator to make the subject unsuitable for participation in the trial.",{"count":581,"type":23},300,[256],"This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.",[30],{"date":586,"type":35},"2026-06-05",{"date":588,"type":35},"2026-03-10",{"date":590,"type":23},"2028-04",{"name":592,"class":90},"Reistone Biopharma Company Limited",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":24,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":43},"100469918","improving-participation-in-pulmonary-rehabilitation-through-peer-support-and-storytelling-100469918","NCT05399056","Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling","ImPReSS-COPD","Inclusion Criteria:\n\n* 40 years or older\n* Received treatment for COPD exacerbation in either inpatient or outpatient setting\n* Referred for pulmonary rehabilitation\n* Ability to understand and communicate in English\n* Willingness to participate in calls with peer coach and to view storytelling videos\n* Working phone\n\nExclusion Criteria:\n\n* Unwilling to attend PR\n* Not eligible for PR based on spirometry or other clinical contraindications as determined by PR staff\n* Currently enrolled in, or completion of 12 or more sessions of PR in the past\n* Comfort measures only or Hospice care\n* Resident of long-term care facility\n* Unable or unwilling to give informed consent",{"count":601,"type":23},305,[133],"Chronic Obstructive Pulmonary Disease (COPD) affects approximately 16 million Americans and is characterized by recurrent exacerbations that lead to 1.5 million Emergency Department visits and 700,000 hospitalizations annually. Pulmonary rehabilitation (PR) is a structured program of exercise and self-management support that has been proven to relieve shortness of breath and increase quality of life when initiated after an exacerbation, but unfortunately, few eligible patients participate. This project will compare the effectiveness of two novel strategies - one involving video narratives of other patients telling their story of how they overcame challenges and completed PR, the other involving telephonic peer coaching with an individual with lived experience - to enhanced usual care, and to each other, at increasing patient participation in PR after an exacerbation.",[30],[165,606,607,608,609,610,611],"Pulmonary rehabilitation","Storytelling","Peer coaching","motivational interviewing","Behavioral interventions","chronic obstructive pulmonary disease",{"date":586,"type":35},{"date":614,"type":35},"2023-02-24",{"date":616,"type":23},"2027-01-31",{"name":618,"class":42},"Baystate Medical Center"]