[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"copd-chronic-obstructive-pulmonary-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:copd-chronic-obstructive-pulmonary-disease":635},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,44,74,99,124,153,175,193,219,245,272,298,327,352,376,397,425,450,473,501,525,545,573,595,615],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652977","creation-of-a-biological-collection-of-bronchiai-and-pulmonary-tissues-from-surgical-waste-100652977",false,"NCT07780630","Creation of a Biological Collection of BRonchiaI and Pulmonary Tissues From Surgical wastE","BRISE","Inclusion Criteria:\n\n* Male or female\n* Adult or children\n* Having required or necessitating, in the context of care or research involving the human person promoted by the Bordeaux University Hospital (ARISE, BIRDIES, ICEBERG, VIRCHILLD) or by Inserm (COBRA), either thoracic surgery such as lobectomy, pneumonectomy or lung transplantation in the Thoracic Surgery Department of the Haut Lévêque Hospital, or bronchial fiberscopy with biopsies and\u002For bronchial brushing and\u002For BAL at the children's hospital of the Pellegrin Hospital or at the Haut Lévêque Hospital.\n* Having received or, for children whose holders of parental authority have received, an information note with the possibility of opposition in accordance with the MR004 (French law - Commission Nationale de l'Informatique et des Libertés (CNIL))\n\nExclusion Criteria:\n\n* Patient or holder of parental authority for children who have expressed their opposition to participation in the research",true,"ALL","1 Year","80 Years",{"count":22,"type":23},650,"ESTIMATED","1 Day","OBSERVATIONAL","The biological samples and associated data will facilitate the successful implementation of the research collaboration between Bordeaux University Hospital and the University of Bordeaux on the pathophysiology of bronchopulmonary diseases. In the longer term, this research could lead to the discovery of new therapeutic targets for asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, and acute respiratory distress syndrome.",[28,29,30],"COPD (Chronic Obstructive Pulmonary Disease)","Asthma (Diagnosis)","Safe Volunteers","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":23},"2026-09-01",{"date":39,"type":23},"2028-12-31",{"name":41,"class":42},"University Hospital, Bordeaux","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100650793","induced-sputum-collection-in-copd-patients-with-and-without-a-vibroacoustic-device-100650793","NCT07751705","Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device","Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male and female participants, aged 40-70 years, inclusive. Women of childbearing potential (i.e. not post-menopausal, defined as amenorrhoeic for at least 12 months, and without documented surgical sterilization such as hysterectomy, bilateral oophorectomy, or tubal ligation) must not be pregnant, as confirmed by a negative urine pregnancy test prior to each sputum induction procedure, and must not be breastfeeding.\n3. Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1\u002FFVC \\\u003C 0.70, consistent with GOLD criteria.\n4. FEV1 between 50% and 80% of predicted (post-bronchodilator).\n5. Body mass index between 18 and 38 kg\u002Fm2\n6. Subgroup \"Current Smokers\": current smoking with at least 15 cigarettes per day over the past 12 months and a cumulative smoking history of at least 10 pack-years, confirmed by a positive urine cotinine test at screening.\n7. Subgroup \"Ex-smokers\": no smoking for at least one year prior to screening and a cumulative smoking history of at least 10 pack-years, confirmed by a negative urine cotinine test at screening\n\nExclusion Criteria:\n\n1. Any clinically relevant disease or condition which, in the opinion of the investigator, may significantly compromise participant safety, affect study outcomes, or prevent adherence to the protocol. Explicitly excluded is cystic fibrosis or interstitial lung disease.\n2. Any condition that, as judged by the investigator, constitutes a contraindication or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to:\n\n   * Any implanted or external electronic-mechanical device in the thoracic projection area (e.g. cardiac pacemaker, implantable cardioverter-defibrillator, cardiac assist devices, implantable drug delivery pumps, neurostimulators)\n   * Coronary heart disease with coronary stents or history of percutaneous coronary intervention or coronary artery bypass grafting\n   * Mechanical heart valve prosthesis\n   * Aortic stent graft or thoracic endovascular implant\n   * Unstable angina pectoris or acute coronary syndrome within the past 6 months\n   * Clinically significant cardiac arrhythmia requiring treatment (e.g. uncontrolled atrial fibrillation, ventricular tachycardia)\n   * Known large pulmonary bullae (\\>1 cm) or history of spontaneous pneumothorax\n   * Unstable rib fractures or thoracic vertebral fractures\n   * Active haemoptysis or known high risk of pulmonary haemorrhage\n   * Therapeutic anticoagulation or known coagulation disorder with increased bleeding risk\n   * Active thoracic malignancy\n   * Thoracic surgery within the past 6 month\n3. Initiation or discontinuation of mucolytic or expectorant agents (e.g., N-acetylcysteine, ambroxol) within 14 days prior to Visit 1 or between study visits. Participants on stable chronic mucolytic therapy (unchanged regimen for at least 4 weeks prior to Visit 1) may be enrolled provided they maintain the same regimen throughout the study.\n4. Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening\n5. Treatment with antibiotics within 2 months prior to screening\n6. Lower respiratory tract infection within 4 weeks prior to screening\n7. Upper respiratory tract infection within 2 weeks prior to screening\n8. History of drug or alcohol abuse within 12 months prior to screening\n9. Participation in a clinical trial involving an investigational medicinal product within 6 months prior to screening\n10. Any condition associated with an increased risk of non-compliance with study procedures (e.g. inability to hold the vibroacoustic emitters against the chest because of severe arthritis, neuromuscular disease, or other condition significantly limiting upper extremity function).","40 Years","70 Years",{"count":54,"type":23},20,"INTERVENTIONAL",[57],"NA","Induced sputum is a non-invasive method to collect samples from the airways. It involves inhaling a saline mist to loosen mucus, which is then coughed up. The samples are used to study markers of lung disease. In some people, this procedure yields only small amounts of sample.\n\nThis study looks at whether adding a vibroacoustic device during sputum induction can increase the amount of sputum collected in patients with chronic obstructive pulmonary disease (COPD). The device applies gentle sound-based vibrations to the chest to help move mucus in the airways.\n\nEach participant undergoes two sputum collection procedures on separate days:\n\none with and one without the device. The order is assigned at random. The main comparison is the amount of sputum obtained with versus without the device in the same person. The study also assesses how well the procedure is tolerated.",[28],[61,62,63,64,65],"Chronic Obstructive Pulmonary Disease","Induced Sputum","Sputum Induction","Airway Sampling","COPD","RECRUITING","2026-08-18",{"date":32,"type":35},{"date":67,"type":35},{"date":71,"type":23},"2026-12",{"name":73,"class":42},"Fraunhofer-Institute of Toxicology and Experimental Medicine",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":55,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":43},"100603235","phase-4-compare-the-effects-of-nebulizer-versus-inhaler-based-therapy-for-copd-using-long-acting-bronchodilators-100603235","NCT07133880","Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators","Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Age \\> 40 years\n2. Either sex\n3. Current smoker or past cigarette smoking history of \\> 10 pack-years\n4. Symptoms of COPD (cough, sputum production, shortness of breath)\n5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening\u002FRun-in visit\n6. A PIFR \\> 30 at screening\n7. FEV1\u002FFVC ratio \\\u003C 70% (within the past 12 months)\n8. Residual volume (RV) ≥ 120% predicted (within the past 12 months\n\nExclusion Criteria:\n\n1. Diagnosis of asthma (Verification via medical record and\u002For patient report)\n2. Previously diagnosed atrial fibrillation with rapid ventricular response (heart rate \\> 110 bpm) or ventricular arrhythmia (ventricular tachycardia) (Verification via medical record and\u002For patient report)\n3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and\u002For patient report)\n4. Acute exacerbation of congestive heart failure (Verification via medical record and\u002For patient report)\n5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and\u002For patient report)\n6. Recent (within 8 weeks) h\u002Fo eye surgery (Verification via medical record and\u002For patient report)\n7. Uncontrolled glaucoma (Verification via medical record and\u002For patient report)\n8. Known diagnosis of liver cirrhosis (Verification via medical record and\u002For patient report)\n9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \\> 2.5 mg\u002FdL - Verification via medical record and\u002For patient report)\n10. Intolerance to any of the study drugs\n11. Patients receiving long-term azithromycin\n12. Planned surgery requiring hospital admission within 3 months\n13. Currently enrolled in a pulmonary rehabilitation program\n14. Inability to give informed consent\n15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants)\n16. Inability to understand instructions or comply with the study protocol\n17. Participation in another investigational drug clinical trial within 30 days of patient study registration\n\nMedical history can be confirmed by medical records and\u002For verbal confirmation from patients. However, Inclusion criteria 6 \\& 7 must be verified by a previous PFT report dated within 6 months of screening",{"count":82,"type":23},72,[84],"PHASE4","The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1\u002FFVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).\n\nThe investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent\u002Flong-acting beta agonist (LAMA\u002FLABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA\u002FLABA therapy given by a DPI.\n\nThe study aims to demonstrate the following:\n\n1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA\u002FLABA by DPI with those receiving LAMA\u002FLABA by nebulizer\n2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline\u002FTransition Dyspnea Index (BDI\u002FTDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA\u002FLABA by DPI with those receiving LAMA\u002FLABA by nebulizer",[28],[61,65,88,89],"Nebulizer","Dry Powder Inhaler","2026-08-14",{"date":92,"type":35},"2026-08-17",{"date":94,"type":35},"2023-12-05",{"date":96,"type":23},"2026-12-01",{"name":98,"class":42},"University of Tennessee Graduate School of Medicine",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":107,"targetDuration":4,"studyType":55,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":43},"100613031","effects-of-blood-flow-restriction-aerobic-exercise-on-inflammation-hypoxia-exercise-capacity-and-lung-function-in-copd-100613031","NCT07261293","Effects of Blood Flow Restriction Aerobic Exercise on Inflammation, Hypoxia, Exercise Capacity, and Lung Function in COPD","Effects of Blood Flow Restriction Aerobic Exercise on Systemic Inflammation, Hypoxia, Exercise Capacity, and Pulmonary Functions in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Randomized Controlled Trial","BFR-COPD","Inclusion Criteria:\n\n* Individuals aged between 40 and 80 years\n* Clinically stable patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2024 criteria with post-bronchodilator FEV₁\u002FFVC \\\u003C 0.70\n* Stable clinical condition (no acute exacerbation within the past 4 weeks)\n* Individuals clinically evaluated and approved as suitable for pulmonary rehabilitation (PR) participation by a cardiology specialist\n* Functional capacity sufficient to participate in PR (e.g., 6-Minute Walk Test ≥150 m)\n* No contraindications to blood flow restriction (BFR) training (e.g., no peripheral vascular disease, no active thrombosis)\n* Ability to understand and follow instructions (adequate auditory and cognitive function)\n\nExclusion Criteria:\n\n* Acute exacerbation of COPD, hospitalization, or systemic corticosteroid treatment within the past 4 weeks\n* Severe cardiovascular disease (uncontrolled hypertension \\>180\u002F110 mmHg, myocardial infarction within the past 6 months, unstable angina, congestive heart failure NYHA Class III-IV)\n* Neurological or orthopedic conditions significantly limiting lower-extremity function (e.g., hemiplegia, amputation, severe osteoarthritis, knee prosthesis)\n* Severe renal impairment (GFR \\\u003C30 mL\u002Fmin\u002F1.73 m²) or severe hepatic failure\n* History of lower-extremity surgery within the past 3 months\n* Active malignancy or systemic infection\n* Anemia or chronic inflammatory\u002Fautoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)\n* History of venous thromboembolism\n* Peripheral arterial disease\n* Physician-diagnosed sarcopenia\n* Psychiatric disorders (major depression, dementia, psychotic disorders) limiting adherence to the study protocol",{"count":108,"type":23},34,[57],"Purpose:\n\nThis study aims to compare the effects of the classical pulmonary rehabilitation (PR) program and blood flow restriction (BFR) applied during low-intensity aerobic exercise within PR on systemic inflammation, hypoxemia, exercise capacity, pulmonary function, respiratory muscle strength, and quality-of-life parameters in individuals with COPD.\n\nMethods:\n\nThis randomized controlled study will include 34 individuals with COPD, allocated into a BFR aerobic group and a control group. Both groups will receive core PR components, including diaphragmatic breathing, pursed-lip breathing, respiratory muscle training, and peripheral muscle strengthening. The BFR group will perform low-intensity aerobic exercise with blood flow restriction, while the control group will perform moderate-intensity aerobic exercise without BFR in accordance with standard PR protocols. All sessions will be supervised by a physiotherapist, twice per week, for eight weeks. Systemic inflammation markers, arterial blood gases, pulmonary function, exercise capacity, quality of life, and symptom scores will be assessed before PR, after the 8th session, and at the end of the program. Data will be analyzed using SPSS 26.0.\n\nExpected Contribution:\n\nThis study aims to provide evidence-based insights into the physiological and clinical effects of low-intensity BFR aerobic exercise within PR and to determine its potential advantages compared with classical PR. Additionally, it seeks to clarify whether low-intensity BFR aerobic exercise may serve as a better-tolerated alternative for COPD patients who experience exercise intolerance during moderate-intensity aerobic training.",[28],[65,113,114,115],"BFR","Aerobic exercise","Exercise capacity","2026-08-13",{"date":92,"type":35},{"date":119,"type":35},"2025-12-01",{"date":121,"type":23},"2026-12-15",{"name":123,"class":42},"Istinye University",{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":55,"phases":134,"briefSummary":135,"conditions":136,"keywords":141,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100650653","balance-training-following-pulmonary-rehabilitation-on-balance-in-people-with-chronic-obstructive-pulmonary-disease-copd-100650653","NCT07750821","Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)","A Pilot Feasibility, Multi-centre, Randomised Controlled Trial of Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)","B-PuRe","Inclusion Criteria:\n\n1. Adults with spirometry confirmed diagnosis of COPD as per GOLD guidelines (FEV1\u002FFVC ratio below 0.7) or physician confirmed COPD diagnosis\n2. Answers yes to one or more of the Three Key Questions\\* or Timed up and Go Test result \\> 11 seconds\n3. An ability and capacity to provide consent to the trial\n\n   * Q1. Have you fallen in the past year? Q2. Do you feel unsteady when standing or walking? Q3. Do you have worries about falling?\n\nExclusion Criteria:\n\n1. Any neurological, musculoskeletal, chronic pain or other diagnoses that, in the opinion of the investigator, would interfere with the ability of the participant to safely complete PR and balance training\n2. Unable to comprehend instruction given verbally in English language\n3. Where there is concern that the primary cause of balance issues could be due to problems with visual function, vestibular disturbance or peripheral neuropathy\n4. Diagnosis of, or patient-reported symptoms of, vasovagal syncope",{"count":133,"type":23},77,[57],"This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.",[28,65,137,138,139,140],"Balance Exercise","Falls, Intervention","Balance Training","Pulmonary Rehabilitation",[130,142,143,65],"Balance","Pulmonary rehabilitation","2026-08-12",{"date":90,"type":35},{"date":147,"type":35},"2026-01-27",{"date":149,"type":23},"2027-05-01",{"name":151,"class":42},"Samantha Harrison",3,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":174},"100576035","study-that-will-evaluate-the-brazilian-population-with-copd-100576035","NCT06780046","Study That Will Evaluate the Brazilian Population With COPD.","Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.","SCOPe","Inclusion Criteria:\n\n* Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1\u002FFVC =2 or CAT \\>=10); or\n* GOLD E (\\>=2 moderate or 1 severe exacerbation - hospitalization); or\n* GOLD 3 and 4 (FEV1 \\\u003C50%).\n\nExclusion Criteria:\n\n* Advanced fibrosing interstitial lung disease (extent \\>=50%); and\u002For\n* High-risk pulmonary hypertension (on triple therapy); and\u002For\n* Active cancer - on systemic therapy","18 Years",{"count":163,"type":23},693,"Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.",[28],{"date":116,"type":35},{"date":168,"type":35},"2025-01-31",{"date":170,"type":23},"2027-09-30",{"name":172,"class":173},"AstraZeneca","INDUSTRY",10,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":55,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":43},"100651667","the-effectiveness-of-tele-pulmonary-rehabilitation-program-on-people-with-chronic-obstructive-pulmonary-disease-copd-after-hospitalization-for-acute-exacerbation-100651667","NCT07762157","The Effectiveness of Tele-pulmonary Rehabilitation Program on People With Chronic Obstructive Pulmonary Disease (COPD) After Hospitalization for Acute Exacerbation","Inclusion Criteria:\n\n* Clinically diagnosed chronic obstructive pulmonary disease (therefore, with or without confirmation by previous spirometry), no limitation on GOLD stage for participants with previous spirometry; AND\n* Aged 18 or above, without limitation on sex, smoking history and medications using; AND\n* Able to participate in the scheduled pulmonary rehabilitation program; AND\n* Owning private electronic devices and Internet connection at\n\nExclusion Criteria:\n\n* With unstable medical conditions; OR\n* With major musculo-skeletal, neurological, psychiatric or cognitive disorders; OR\n* Refusal on clinical study.",{"count":182,"type":23},40,[57],"Introduction: There are great impacts of chronic obstructive pulmonary disease (COPD) over healthcare and economic systems globally. Managing COPD stably in community is still a challenging topic due to its progressive nature, it is valuable to be studied with a view to improving the health status and quality of life in people with COPD and thus relieving the healthcare and economic burdens. Pulmonary rehabilitation (PR) was proven to be cost-effective with clinical benefits in optimizing quality of life, physical conditions and reducing hospital re-admissions rate in people with COPD. Traditionally, PR training was conducted under professional supervision in a face-to-face format. Community-based PR, like tele-rehabilitation, centre-based and homebased rehabilitation are emerging as an effective alternative to traditional PR. Promoting community-based rehabilitation is possibly one of the ways to engage people with chronic diseases in selfmanagement at their doorstep, which will help to tackle the escalating aging population and their heavy burden to the public healthcare system in Hong Kong.\n\nObjectives: The objectives of this study are:\n\n* To evaluate the clinical effectiveness of the newly developed tele-pulmonary rehabilitation program on people with COPD after hospitalized acute exacerbation,\n* To explore participants' experience towards the program and develop a deeper understanding about the enablers and barriers faced by participants in joining the - tele-pulmonary rehabilitation program for quality assessment and improvement Methodology: Quasi-experimental design will be adopted in quantitative study, participants will join an eight-session tele-PR program in the intervention group, and participants will join the control group when pending for traditional out-patient based PR program. Purposive sampling will be adopted, participants should be clinically diagnosed COPD, able to participate in scheduled PR program and able to listen, speak, read and understand Chinese. Four domains of outcome measures will be collected, including participant profile, physical health status, health-related quality of life and healthcare resources utilization, for evaluation. Qualitative study with phenomenological approach will be adopted to discover participants' experience in the service. Semistructured, individual face-to-face in-depth interviews will be conducted once participants complete the tele-pulmonary rehabilitation program. Significance: This study will provide solid evidence on the effectiveness of tele-pulmonary rehabilitation program for people with COPD after hospitalized for acute exacerbation.",[28],"2026-08-11",{"date":116,"type":35},{"date":119,"type":35},{"date":190,"type":23},"2027-03-31",{"name":192,"class":42},"North District Hospital",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":17,"sex":18,"minAge":161,"maxAge":20,"enrollmentInfo":200,"targetDuration":4,"studyType":55,"phases":202,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":43},"100614863","phase-1-inhaled-rb042-in-healthy-adult-volunteers-and-healthy-adult-smokers-100614863","NCT07285122","Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease","A Phase 1a\u002F1b, Randomised, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RB042 Administered Via Inhalation to Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Part A, B, C only: Participants must be 18 to 55 years of age inclusive.\n* Part D only: Patients must be 40 to 80 years of age inclusive.\n* Part A, B, C only: Participants must be overtly healthy as determined by medical evaluation.\n* Part C only: have a ≥10 pack years smoking history, have smoked tobacco products (cigarettes, cigars, or equivalent) regularly for the past 12 months, and currently smoke daily.\n* Part D only: Former smokers (smoked a total of 100 or more cigarettes in their lifetime but has not smoked in the past 6 months to over a year).\n* Part A, B, C only: Have forced expiratory volume (FEV1) ≥80% predicted and FEV1 to FVC ratio (FEV1\u002FFVC) ≥0.7 at Screening and on Day -1.\n* Part D only: Have forced expiratory volume (FEV1) between ≥30% and \\\u003C80% predicted and FEV1 to FVC ratio (FEV1\u002FFVC) \\\u003C0.7 post-bronchodilation at Screening.\n* Part D only: Documented clinical diagnosis of COPD per 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) for greater than ≥1 year and a history of chronic bronchitis as evidenced by frequent productive cough in the 2-year period immediately before Screening.\n* Part D only: Have clinically stable COPD with no moderate to severe exacerbations in the past 3 months.\n* Part D only: Must be on stable assigned maintenance COPD therapy.\n* Body weight at least 50 kg and have a body mass index (BMI) within the range 18.0 and 32.0 kg\u002Fm2 (inclusive)\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating.\n* Participants must agree to use an approved method(s) of highly effective contraception as defined in the protocol.\n\nExclusion Criteria:\n\n* Part A, B and C only: Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or study outcomes.\n* Part D only: Current unstable clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or study outcomes.\n* Part A, B and C only: Chronic or active respiratory disease (e.g., asthma, COPD) or history of angioedema within 3 years.\n* Part D only: Patients with other respiratory conditions other than COPD (for example, clinically significant asthma, active tuberculosis, pulmonary fibrosis) are excluded if these conditions are the primary cause of their respiratory symptoms.\n* Active or chronic liver disease, or abnormal liver function tests (ALT, AST, or bilirubin outside reference range, except Gilbert's syndrome).\n* QTcF \\>450 msec (males) or \\>470 msec (females).\n* Renal impairment (creatinine clearance \\\u003C90 mL\u002Fmin) or thrombocytopenia (\\\u003C150 × 10⁹\u002FL).\n* Positive test for hepatitis B surface or core antigen, hepatitis C (unless HCV-RNA negative), or HIV.\n* Active respiratory infection within 5 days before study start.\n* Recent or concurrent use of medications, herbal supplements, vaccines, or blood products that could interfere with study safety or interpretation.\n* Participation in another investigational study within 30 days, or blood donation \\>400 mL within 30 days.\n* Parts A, B and D only: Regular smoking (≥1 day per week) within 6 months prior to dosing, or a positive urine cotinine test at screening or Day -1.\n* Excessive alcohol consumption (\\>21 drinks\u002Fweek for males or \\>14 for females).\n* History of severe drug reaction or anaphylaxis.\n* Part B and C only: Contraindication to, or unwillingness to undergo, bronchoscopy.\n* Any psychiatric or medical condition that, in the investigator's opinion, could compromise safety or compliance.",{"count":201,"type":23},105,[203],"PHASE1","This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.",[206,207,28,65],"Healthy","Healthy Smoker",[65,61,209,210],"Healthy smoker","Healthy volunteer","2026-08-10",{"date":144,"type":35},{"date":214,"type":35},"2026-02-16",{"date":216,"type":23},"2027-10",{"name":218,"class":173},"Atisama Therapeutics",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":226,"targetDuration":4,"studyType":55,"phases":228,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":244},"100650630","remote-intervention-versus-routine-monitoring-in-copd-patients-with-chronic-hypercapnia-receiving-home-non-invasive-respiratory-support-100650630","NCT07751003","Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support","A Randomized Controlled Trial of Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support","Inclusion Criteria:\n\n* Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry.\n* Hospitalized due to an acute exacerbation of COPD.\n* Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia.\n* Already receiving or planned to receive long-term home non-invasive respiratory support.\n* Capable of using a smartphone or tablet for video communication and has internet access.\n* Willing to participate and provides written informed consent.\n\nExclusion Criteria:\n\n* Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer).\n* Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome).\n* Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management.\n* Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy).\n* Pregnant or lactating women.",{"count":227,"type":23},236,[57],"This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.",[28,231,232],"Acute Exacerbation of COPD","Hypercapnia",[234,235],"Home management","Telehealth","2026-08-03",{"date":238,"type":35},"2026-08-06",{"date":240,"type":23},"2027-08-01",{"date":39,"type":23},{"name":243,"class":42},"Sir Run Run Shaw Hospital",4,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":55,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100650569","phase-4-airway-dysfunction-occlusions-and-remodeling-copd-patients-and-mepolizumab-100650569","NCT07749001","Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab","Airway Dysfunction, Occlusions and RemodEling: COPD Patients and Mepolizumab (ADORE)","ADORE","Inclusion Criteria:\n\n* Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.\n* Provision of written, informed consent prior to any study specific procedures.\n* Males and females 55-85 years of age.\n* An eosinophilic phenotype with elevated BEC with a documented measurement of ≥ 300 cells\u002FµL at Baseline\u002Fscreening Visit 1.\n* CT mucus-count ≥ 3 on baseline\u002Fscreening CT OR on previous clinical CT acquired within last 12 weeks AND evaluable for mucus occlusions.\n* Moderate to severe COPD with frequent exacerbations, defined as:\n\n  * A clinically documented history of COPD as defined by the American Thoracic Society\u002FEuropean Respiratory Society for at least 1 year.\n  * A post-salbutamol FEV1\u002FFVC ratio of \\\u003C 0.70 and a post-salbutamol FEV1 ≥ 30% and \\\u003C 80% predicted at screening.\n  * A well-documented history (e.g., medical record verification) of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening:\n\n    1. At least one qualifying exacerbation must have occurred while participant is on ICS-LAMA-LABA.\n    2. Moderate exacerbations must have been treated with systemic corticosteroids.\n    3. Severe exacerbations are those requiring hospitalization (i.e., ≥ 24 hours)\n* Smoking status: Ex-cigarette smokers (quit ≥ 1 year) with a history of cigarette smoking of ≥ 10 pack-years at Baseline\u002Fscreening Visit 1.\n* Participants should be on maintenance inhaler therapy, defined as ICS+LAMA+LABA, either as multiple inhalers or a single combination inhaler for at least 3 months prior to Baseline Visit 1.\n* Participants on adjunctive COPD therapies such as roflumilast, chronic macrolide antibiotics may participate, provided they have been on these medications for at least 6 months, and on a stable dose for at least 3 months immediately prior to Baseline Visit 1. These participants should remain on these therapies for the duration of the study.\n* Women of non-childbearing potential will be included.\n\nSuch females will be:\n\nPermanently sterile due to one of the following procedures:\n\n1. Documented hysterectomy.\n2. Documented bilateral salpingectomy.\n3. Documented bilateral oophorectomy. For permanently sterile individuals due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), investigator discretion should be applied to determining study entry. If reproductive status is questionable, additional evaluation should be considered.\n\nNote: Documentation will stem from review of participant's medical records, medical examination, or medical history interview.\n\nPostmenopausal female. Females who are confirmed post-menopausal for ≥ 1year. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\nA high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in participants not using hormonal contraception or HRT. In the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.\n\nFemales on HRT and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n\nExclusion Criteria:\n\n* Patient has an implanted mechanically, electrically, or magnetically-activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and\u002For ear implants) (at the discretion of the MRI Technologist).\n* In the Investigator's opinion, participant suffers from any physical, psychological, or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.\n* Participant is unable to perform spirometry or plethysmography maneuvers.\n* Participant is unable to perform MRI and CT breath-hold maneuvers.\n* Participants with any diagnosis of asthma at any time are excluded. A diagnosis of asthma should be based on both a history of typical respiratory symptoms combined with evidence of variable expiratory airflow limitation at the time of diagnosis consistent with GINA 2023 or other accepted guidelines.\n* Participants with α1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.\n* Participants with pneumonia, active COPD exacerbation at screening\u002Fbaseline visit, or lower respiratory tract infection within the 4 weeks prior to Baseline Visit 1.\n* Participants with a history of, or plan for lung volume reduction surgery\u002Fendobronchial valve procedure.\n* Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Baseline Visit 1 are excluded. Participants who are in the maintenance phase of a pulmonary rehabilitation program may participate.\n* Patients requiring oxygen supplementation for more than 12 hours per day are excluded. Non-continuous (i.e., 12 hours or less per day) oxygen is permitted up to 2 L\u002Fmin at screening.\n* Participants with Cor-pulmonale resulting in right heart failure, severe pulmonary hypertension.\n* Participants with chronic hypercapnia requiring BiPAP.\n* Participants with unstable cardiovascular disease.\n* Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA, also known as Churg-Strauss Syndrome), or Eosinophilic Esophagitis.\n* Participants with a known, pre-existing parasitic infection within 6 months of Baseline Visit 1.\n* Participants with a current malignancy or previous history of cancer in remission for less than 12 months prior to Baseline Visit 1 (localized carcinoma of the skin or cervix resected for cure not excluded).\n* Participants with a known immunodeficiency (e.g., human immunodeficiency virus-HIV).\n* Participants with cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. NOTE: stable non-cirrhotic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (in whom Hepatitis D (HDV) has been excluded)) or C are acceptable if participant otherwise meets entry criteria.\n* Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease\u002Fcondition exacerbated during the study.\n* Previous exposure to monoclonal antibodies targeting IL-5\u002F5R, IL-4R\u002FIL-13, IL-33, or TSLP within 6 months or 5 half-lives, prior to Baseline Visit 1.\n* Previous documented failure with anti-IL-5\u002F5R or anti-IL-4R\u002FIL-13 therapy.\n* Other monoclonal antibodies: participants who have received any monoclonal antibody within 5 half-lives of Screening Visit 1.\n* Participants who have received short term use of oral corticosteroids within 4 weeks of Visit 1.\n* Previous randomization in the present study.\n* Concurrent enrolment in another clinical trial.\n* 12-lead ECG at Baseline Visit 1: participants with QT interval corrected with Fridericia's formula (QTcF) \\> 450 ms (or QTcF \\> 480 ms in participants with bundle branch block).\n\n  * QTcF is the QT interval corrected for heart rate according to Fridericia's formula that is selected for this study. It is either machine-read or manually over-read when not automatically machine read. This specific formula must be used to determine eligibility for an individual participant.\n  * Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Baseline Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.\n  * Where a single ECG demonstrates a prolonged QTcF interval, obtain two more ECGs readings at a minimum of 2 minutes apart over a brief recording period (e.g., 5-10 minutes), The average of the triplicate QTcF measurements should be used to determine eligibility.\n* Participants with a known allergy or sensitivity to any of the study interventions or study treatment, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.\n* Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.\n* Participants with conditions that will limit the validity of informed consent to participate in the study, e.g., uncontrolled psychiatric disease or intellectual deficiency.\n* A known or suspected history of alcohol or drug abuse within 2 years prior to Baseline Visit 1.\n* For sputum induction, participants who have had previous bronchospasm or prior intolerance to a hypertonic saline solution, poorly controlled COPD on the day of sample collection, or oxygen saturation of less than 88% on room air will not take part in the induced sputum collection.\n* Female participants: Women of childbearing potential (after menarche) will NOT be enrolled.","55 Years","85 Years",{"count":256,"type":23},36,[84],"The goal of this study is to evaluate the effect of mepolizumab on patients with COPD using MRI and CT imaging as well as breathing tests. The study will evaluate the response to this medication after 24 and 48 weeks of treatment. The main questions it aims to answer are:\n\n1. Does mepolizumab improve ventilation defect percent as measured on 129-Xenon MRI in adults with COPD.\n2. Does mepolizumab improve the amount of mucus plugs in the lungs as measured by lung CT in adults with COPD.\n\nParticipants will:\n\n1. Take mepolizumab by subcutaneous injection every 4 weeks for the duration of the study.\n2. Visit Robarts 4 times over 48 weeks for tests and imaging.",[28],[261,262,263,65],"129-Xenon","Pulmonary Function","Magnetic Resonance Imaging","2026-07-31",{"date":238,"type":35},{"date":267,"type":23},"2026-10-01",{"date":269,"type":23},"2028-04-01",{"name":271,"class":42},"Western University, Canada",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":55,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100589765","effectiveness-of-ditm-versus-imt-in-copd-patients-100589765","NCT06958666","Effectiveness of DITM Versus IMT in COPD Patients","Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study","Inclusion Criteria:\n\n* Diagnosed as COPD according to \"GOLD2024\"\n* Lung function results FEV1\u002FFVC\\\u003C60%\n* Patients with stable COPD who meet one of the following criteria: (A)with CAT score ≥10 or mMRC≥2; (B) ≥2 moderate acute exacerbation or ≥1 hospitalization in the past 12 months\n* Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro Ellipta) as maintenance drug for COPD management\n* Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity, his\u002Fher guardian shall act on his\u002Fher behalf to read and sign the informed consent form.\n\nExclusion Criteria:\n\n* Unstable angina or severe arrhythmia\n* Severe weakness-related fatigue, such as in advanced congestive heart failure or chemotherapy-related fatigue\n* Unstable mental illness with a risk of self-harm or harm to others\n* Severe cognitive impairment, progressive neuromuscular disease\n* Pregnant and breastfeeding women\n* Life expectancy of less than 6 months\n* Pregnant and breastfeeding women\n* Inability to cooperate with pulmonary function tests\n* Inability to complete the entire follow-up period\n* Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.",{"count":280,"type":23},410,[57],"The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1\u002FFVC \\\u003C 60%). The main questions it aims to answer are:\n\nDoes DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength.\n\nParticipants will:\n\nDITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback.\n\nIMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training.\n\nDITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions.\n\nControl Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.",[28],[140,65,285,286,287,288],"GOLD2024","Global Initiative for Chronic Obstructive Lung Disease","Digital Inhaled Therapy Management","Inspiratory Muscle Training","2026-07-23",{"date":291,"type":35},"2026-07-24",{"date":293,"type":35},"2025-06-30",{"date":295,"type":23},"2028-05",{"name":243,"class":42},9,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":55,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":43},"100647098","moblo2-to-maintain-oxygenation-100647098","NCT07704567","MoblO2 to Maintain Oxygenation","MOBoxy: MoblO2 to Maintain Oxygenation","SSeifert","Inclusion Criteria:\n\nPreviously-diagnosed COPD or chronic interstitial lung disease Prescribed O2 for use with exertion at least 1 month prior to enrollment Age 25 years old or greater Self-reported stable symptoms and stable oxygen needs for at least 2 weeks Consent to using compressed gas tanks to deliver O2 during the 2-week study period\n\nExclusion Criteria:\n\nActive angina Musculoskeletal disease that precludes physical activity Need for O2 at rest Patient needing more than 10 L\u002Fmin continuous flow with exertion on O2 screen Patient prescribed 10L\u002Fmin continuous flow (or more) by their prescribing practitioner","25 Years","95 Years",{"count":309,"type":23},48,[57],"Many patients with chronic lung disease (e.g., chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD)) require supplemental oxygen (O2) at some point during their disease course. Practitioners prescribe O2 to patients with chronic lung disease in hopes of the following: 1) that it will limit desaturation events and combat breathlessness, thus preventing the frustratingly slow pace and numerous rest breaks patients are forced to adopt while doing even simple tasks; 2) that it will allow patients to be more active physically (perhaps increase their ability to exercise) and socially (perhaps leave the home more often); 3) that it will stave off putative complications of hypoxemia (e.g., cognitive dysfunction, pulmonary hypertension) and 4) that it will improve health-related quality of life (HRQL).\n\nHowever, despite the rationale for O2, and prescribers' good intentions, patients generally view O2 with frustration and fear - it threatens their HRQL, which is already impaired by having a condition that imposes itself on every aspect of their lives. Nasal cannulas and delivery devices call unwanted attention to patients when they are out in public. O2 users feel stigmatized and are often viewed as \"smokers who get what they deserve, even if they never smoked a day in their lives\" - or as disabled, sick or even infectious. O2 steals patients' independence, forcing them to plan their lives around it. The anxiety that patients and their caregivers experience around running out of oxygen, or not getting enough, immobilizes them and restricts participation in activities outside of the home. O2 disrupts the home environment, adding stress, and creating a burden for patients' caregiver-loved-ones who are often saddled with the responsibility of ensuring adequate equipment and supply of O2, and O2 is a constant reminder to patients they are living with a condition that could shorten their lives.\n\nO2 delivery equipment is typically heavy, unwieldy and intimidating. Different recommendations (e.g., insurance companies use 88% as a cut-off for SpO2, while many practitioners focus on 90%) make it confusing for patients, which almost certainly affects adherence. O2-requiringpatients are starving for things that can make their lives easier. An auto-adjusting O2 delivery device - one that automatically delivers the correct amount of O2 to maintain blood oxygen at desired, pre-set levels - would alleviate the need for patients to constantly (incessantly for many) monitor their peripheral oxygen saturation (SpO2) and adjust O2flow to meet the demands as exertion levels vary .\n\nThe MoblO2 device is a battery-operated, light-weight, closed-loop O2 delivery device that houses a regulator (which attaches to compressed gas O2 tanks) and adjusts O2 flow to meet a pre-set blood oxygen level. A pulse oximeter is worn on the ear and transmits via Bluetooth to the device, which adjusts an internal valve to control flow on a second-to-second basis.\n\nThe user sets the dial to the highest flow of O2 needed to meet the demands of activities they might perform (up to 15 liters per minute), and the device adjusts flow, up to the pre-set level to maintain SpO2 at a preset level (e.g., \\> 90%). To conserve O2 supply in the tank - and to avoid over-oxygenation (which could be problematic for a small percentage of patients with the most severe COPD) - the MoblO2 begins to limit O2 flow at a SpO2 of 93%. The device can be manually over-ridden by the user, and should the battery run out - or the device fail for some unforeseen reason - the default position is valve open, so the users receive whatever flow of oxygen has been set on the dial.\n\nGiven the substantial burdens of O2 on patients and their families, the hassles patients describe with having to monitor their SpO2 and repeatedly adjust the flow of O2 to meet their needs, patients and experts around the world have called for improvements in O2 delivery equipment. The MoblO2 is just such a remarkable improvement and a giant step forward in helping to ease the burdens of O2 on patients who require it.\n\nThe purpose of this study is to investigate the effects of the MoblO2 O2 delivery device on a range of outcomes, including physical activity, amount (liters) O2 use; maintenance of adequate SpO2 levels; patient reported outcomes including symptoms, HRQL and satisfaction with the MoblO2 O2 device.",[28,313],"Intersitital Lung Disease",[65,315,316,317,318],"ILD","supplemental oxygen","symptoms","oxygen delivery","2026-07-21",{"date":321,"type":35},"2026-07-22",{"date":323,"type":35},"2026-07-09",{"date":240,"type":23},{"name":326,"class":173},"Minnesota HealthSolutions",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":55,"phases":337,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":43},"100648369","effects-of-alternate-nostril-breathing-and-bellows-breath-in-copd-patients-100648369","NCT07719192","Effects of Alternate Nostril Breathing and Bellows Breath in COPD Patients","Effects of Alternate Nostril Breathing and Bellows Breath on Sputum Clearance, Pulmonary Function Test and Quality of Life Among COPD Patients","Inclusion Criteria:\n\n* diagnosed case of copd patients\n* Age group:above 10 years\n* Clinically stable\n* Able to understand or perform breathing exercise\n\nExclusion Criteria:\n\n* current acute pulmonary infection\n* History of pneumothorax or hemoptysis\n* Patients who was in stage 4 of functional classification of fatigue,palpation,dyspnea or anginal pain","10 Years",{"count":336,"type":23},54,[57],"COPD is a common respiratory disease characterized by progressive airflow obstruction, dyspnea, chronic cough, and sputum production. Alternate nostril breathing and bellows breath are pranayama-based breathing techniques that may improve respiratory function and overall well-being. This randomized clinical trial aims to compare the effects of these techniques on sputum clearance, pulmonary function tests, and quality of life in COPD patients. The study will be conducted at Punjab Institute of Cardiology using convenient sampling. Participants will be divided into two groups: Group A will perform alternate nostril breathing, while Group B will perform bellows breath exercises for 15-20 minutes daily over 3-4 weeks. Outcome measures include sputum clearance, spirometry, and quality of life questionnaires. Data will be analyzed using SPSS with significance set at p \\\u003C 0.05. The study may support the use of cost-effective, noninvasive breathing techniques for improving pulmonary function and quality of life in COPD patients.",[28],[341,342,65,343],"Alternate nostril breathing","Bellows breath","Sputum clearance","2026-07-17",{"date":321,"type":35},{"date":347,"type":23},"2026-06",{"date":349,"type":23},"2026-08-01",{"name":351,"class":42},"Riphah International University",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":55,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":375,"locationsCount":43},"100647891","effects-of-autogenic-drainage-and-flutter-device-in-copd-100647891","NCT07713043","Effects of Autogenic Drainage and Flutter Device in COPD","Comparative Effects of Autogenic Drainage and Flutter Device on Dyspnea, Pulmonary Function Test and Functional Capacity in COPD","Inclusion Criteria:\n\n* Age group: Middle age adults (40-60 years), medically stable\n* Both gender\n* Diagnosis based on GOLD criteria ((FEV₁\u002FFVC ratio \\\u003C 0.70).\n* Moderate COPD with no acute exacerbations in the past 4-6 weeks.\n* Participants must be able to perform Autogenic drainage and Flutter device physically and mentally.\n* Voluntary participation with consent.\n\nExclusion Criteria:\n\n* Cardic Diseases (Acute MI, Congestive Heart Failure)\n* Musculoskeletal Impairements\n* Using Non-invasive Ventilation\n* Recent lung diseases (Respiratory failure, pneumothorax)\n* Hemodynamic instability\n* Uncoorperative patients\n* Cognitive Impairement scale\n* Participants excluded if they did not consent\n* Comorbidities affecting exercise tolerance","60 Years",{"count":361,"type":23},42,[57],"COPD is a progressive lung disease that includes emphysema and chronic bronchitis and is a major cause of morbidity and mortality worldwide. Airway clearance techniques help improve mucus removal, reduce dyspnea, and enhance quality of life in COPD patients. This study aims to compare the effects of autogenic drainage and flutter device on dyspnea, pulmonary function, and functional capacity in patients with COPD. A randomized clinical trial will be conducted at Gulab Devi Teaching Hospital using convenient sampling. Participants will be divided into two groups: Group A will receive autogenic drainage, while Group B will use the flutter device. Interventions will be performed daily for 20-30 minutes over 6 weeks. Outcome measures will include dyspnea severity scale, spirometry, and 6-minute walk test. Data will be analyzed using SPSS with significance set at p \\\u003C 0.05. The study may provide evidence for effective, non-invasive, and cost-effective management strategies for COPD patients.",[28],[366,65,367,368,369,370],"Autogenic drainage","Dyspnea","Flutter device","Functional capacity","Pulmonary function test",{"date":372,"type":35},"2026-07-20",{"date":347,"type":23},{"date":349,"type":23},{"name":351,"class":42},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":382,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":55,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":43},"100645715","modulating-locomotor-respiratory-coupling-through-adaptive-exoskeleton-assistance-in-patients-with-copd-100645715","NCT07703527","Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD","Inclusion Criteria:\n\n* COPD Diagnosis \\& Severity: Documented FEV1\u002FFVC ratio of \\\u003C 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD).\n* Age Requirement: Must be between 45 and 75 years old.\n* Body Mass Index (BMI): Must have a BMI of less than 35 kg\u002Fm\\^2.\n* Medical Clearance \\& Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician.\n\nExclusion Criteria:\n\n* Failing to pass the initial spirometry test.\n* Not being formally cleared for participation by a physician.\n* Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.","45 Years","75 Years",{"count":174,"type":23},[57],"1\\) Purpose: To improve pulmonary rehabilitation outcomes for individuals with COPD by evaluating the effectiveness of a hip-assisted exoskeleton during a single pulmonary rehabilitation session. 2) Eligibility criteria: Participants must be between 45-75 years old, any gender, but must have a BMI of less than 35 kg\u002Fm\\^2, free from co-morbidities that may affect walking patterns, and must have moderate to severe COPD with no other pulmonary or cardiac issues. (Eligible participants will undergo a screening process which includes 6-minute walking test, medical history exam, and spirometry evaluation.) 3) Intervention and evaluation: The experimental collection will be conducted at the Biomechanics Research Building at the University of Nebraska at Omaha. Participants are required to participate in two sessions on two separate days, both including a 30-minute walking session with one session wearing the hip exoskeleton and the other session without the device.",[28],"2026-07-08",{"date":390,"type":35},"2026-07-14",{"date":392,"type":23},"2026-09",{"date":394,"type":23},"2028-09",{"name":396,"class":42},"University of Nebraska",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":405,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100640617","quantitative-chest-ct-and-multi-omics-to-distinguish-asthma-from-copd-and-predict-treatment-response-100640617","NCT07602192","Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response","Prospective Multicenter Cohort to Discriminate Asthma Versus Chronic Obstructive Pulmonary Disease and Predict Treatment Response Using Quantitative Chest CT and Multi-Omics","CTOMICS","Inclusion Criteria:\n\n* Age ≥19 years\n* COPD group: post-bronchodilator FEV1\u002FFVC \\\u003C 0.70\n* Asthma group: clinically confirmed diagnosis of asthma by a physician\n* Able to provide voluntary written informed consent\n\nExclusion Criteria:\n\n* Acute exacerbation or active lower respiratory tract infection (e.g., pneumonia) within the past 4 weeks\n* Pregnancy or breastfeeding\n* Inability to undergo chest CT (e.g., poor cooperation or severe medical condition)\n* Refusal to consent to study procedures","19 Years",{"count":407,"type":23},200,"This study aims to improve the diagnosis and treatment prediction of asthma and chronic obstructive pulmonary disease (COPD) by combining quantitative chest computed tomography (CT) imaging with multi-omics data.\n\nAdults with asthma or COPD will be enrolled and undergo routine clinical evaluations, pulmonary function tests, blood tests, and chest CT scans. Additional samples, such as sputum and microbiome specimens, may also be collected. No experimental drugs or devices will be administered as part of this study.\n\nResearchers will analyze CT imaging features together with clinical, laboratory, and biological data to better distinguish asthma from COPD and to identify factors that may predict treatment response. The findings are expected to contribute to more precise and personalized management of chronic airway diseases.",[29,28],[411,412,413,61,414],"Quantitative chest CT","Airway disease","Asthma","Treatment response","2026-07-03",{"date":417,"type":35},"2026-07-07",{"date":419,"type":35},"2025-12-22",{"date":421,"type":23},"2027-12-22",{"name":423,"class":42},"Korea University Guro Hospital",2,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":432,"targetDuration":434,"studyType":25,"phases":4,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100640105","the-study-of-chronic-obstructive-pulmonary-disease-copd-participants-treated-with-dupilumab-stride-registry-100640105","NCT07612878","The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry","STRIDE","Inclusion Criteria:\n\n* COPD patients who are newly referred to start dupilumab treatment\n* Age ≥ 40 years\n* Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit\n\nExclusion Criteria:\n\n* Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)\n* Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments\n* Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial",{"count":433,"type":23},350,"24 Months","The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and\u002For severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.",[28],[65,438,439,61,440,441],"Dupilumab","Dupixent","Exacerbation","Home Spirometry","2026-06-30",{"date":444,"type":35},"2026-07-02",{"date":264,"type":23},{"date":447,"type":23},"2029-11-30",{"name":449,"class":173},"Sanofi",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":458,"targetDuration":4,"studyType":55,"phases":460,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100537910","phase-3-a-study-evaluating-the-efficacy-of-budesonide-glycopyrronium-and-formoterol-fumarate-metered-dosed-inhaler-on-cardiopulmonary-outcomes-in-chronic-obstructive-pulmonary-disease-100537910","NCT06283966","A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease","A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)","THARROS","Inclusion Criteria:\n\n1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing\n\n   the ICF.\n2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)\n3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1\u002FFVC ratio \\\u003C 70%\n\n   at V1.\n4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking;\n\n   defined as (number of cigarettes per day\u002F20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6\n\n   months prior to V1.\n5. A baseline peripheral blood eosinophil count of ≥ 100 cells\u002Fmm3 assessed at Visit 1 by\n\n   the central laboratory\n6. A CAT score of ≥ 10 at Visit 1.\n7. Participant must fulfill at least 1 of the 4 CV disease\u002Frisk factor criteria below \\[(a), (b),\n\n   (c), or (d)\\]:\n   1. : Established CV Disease\n   2. : Combination of CV risk factors:\n\n      * Hypertension\n      * Diabetes Mellitus\n      * Chronic Kidney Disease\n      * Dyslipidemia\n      * Obesity\n   3. : High risk of CV disease determined using an established CV risk assessment\n\n      tool.\n   4. : CT coronary Artery Calcification\n8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as\n\n   required by the protocol.\n9. Willing to visit at the study site or participate in virtual visits as required per the protocol\n\n   to complete all study assessments.\n10. A female is eligible to enter and participate in the study if the female is of:\n\n    * Non-childbearing potential: either permanently sterilized or who are post-menopausal.\n    * Childbearing potential: has a negative serum pregnancy test at V1 and must use one\n\n    highly effective form of birth control.\n11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.\n\nExclusion Criteria:\n\n1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.\n2. End-stage renal disease requiring renal replacement therapy\n3. History of heart or lung transplant or actively listed for heart or lung transplant.\n4. Implanted left ventricular assist device or implant anticipated in \\\u003C 3 months.\n5. History of lung cancer and\u002For treatment for lung cancer within the 5 years prior to Visit 1.\n6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:\n\n   1. An MI or unstable angina in the last 8 weeks\n   2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.\n\n   NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.\n7. Pneumonia and\u002For moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1\n8. Any life-threatening condition, including malignancy, with a life expectancy \\\u003C 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.\n9. Use of maintenance ICS treatment within the past 12 months.\n10. Unable to abstain from protocol-defined prohibited medications\n11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).\n12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.\n13. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n15. Previous randomization in the present study.\n16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding",{"count":459,"type":23},5250,[461],"PHASE3","This study will evaluate the effect of triple ICS\u002FLAMA\u002FLABA therapy with BGF MDI 320\u002F14.4\u002F9.6 μg on cardiopulmonary outcomes relative to LAMA\u002FLABA therapy with GFF MDI 14.4\u002F9.6 μg in a population with COPD and elevated cardiopulmonary risk.",[28],"2026-06-23",{"date":466,"type":35},"2026-06-24",{"date":468,"type":35},"2024-02-21",{"date":470,"type":23},"2027-12-03",{"name":172,"class":173},921,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":55,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":43},"100425460","home-based-pulmonary-rehabilitation-for-copd-patients-100425460","NCT04820257","Home-based Pulmonary Rehabilitation for COPD Patients","Inclusion Criteria:\n\n* Men and women age 40 years and older\n* FEV1 \\\u003C80% or less (forced expiratory volume in one second) as documented by pulmonary function.\n* Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.\n* The patients must be able to access a smart-phone or computer tablet with internet service.\n\nExclusion Criteria:\n\n* Unable to perform low intensity exercise.\n* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.\n* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).","100 Years",{"count":481,"type":23},80,[57],"Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.\n\nThe program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.\n\nThe proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.",[485],"COPD, Chronic Obstructive Pulmonary Disease",[487,488,489,490,491,492],"tele-health","behavioural change","motivational interviewing","home-based exercise","self-related health","quality of life",{"date":494,"type":35},"2026-06-26",{"date":496,"type":23},"2026-11-01",{"date":498,"type":23},"2028-12",{"name":500,"class":42},"Karolinska Institutet",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":55,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":43},"100644308","tele-pulmonary-rehabilitation-for-copd-patients-living-in-peripheral-areas-100644308","NCT07666854","Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas","Examining the Feasibility and Effectiveness of a Remote Group Respiratory Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease Living in Peripheral Areas as a First Step to Policy Change","TELE-PR-PRPRL","Inclusion Criteria:\n\n* Male and females Patients with COPD based on accepted criteria who are eligible for reimbursement of pulmonary rehabilitation (PR) according to the Israeli \"health basket\" criteria including one of the following:\n\n  * FEV1 below 50%\n  * Severe exacerbation (hospitalization) in the previous year\n  * Two moderate exacerbations in the previous year\n* Willingness to initiate a PR or TPR programs.\n* Living in geographic peripheral area.\n* Ability to perform the TPR program or traditional PR activities as assessed by a member of the study team prior to enrollment.\n* Agree to participate, with signed informed consent.\n* Age \\> 18.\n\nExclusion Criteria:\n\n* Uncontrolled comorbidity (e.g uncontrolled congestive heart failure).\n* Inability to operate the mobile application.\n* Without a mobile device or computer.\n* An exacerbation in the 2-months prior to randomization.\n* Completed PR program in the last 12 months.\n* Pregnancy.\n* Patients with cognitive impairment.",{"count":510,"type":23},110,[57],"Pulmonary rehabilitation (PR) is a key non-pharmacological intervention for patients with chronic obstructive pulmonary disease (COPD), yet it remains underutilized, particularly among patients living in peripheral areas due to limited access, travel distance, and logistical barriers. Tele-pulmonary rehabilitation (TPR) has the potential to improve access to care, but its feasibility and effectiveness as a group-based intervention have not been well established.\n\nThe aim of this study is to evaluate whether a group-based TPR program can improve treatment initiation and adherence compared to usual care, defined as referral to standard PR, among COPD patients living in peripheral areas. In addition, the study will assess the effect of the intervention on COPD exacerbations, symptom burden, quality of life, and patient satisfaction.\n\nThis is a prospective randomized controlled trial that will enroll patients with COPD who are eligible for PR according to the Israeli health basket criteria and have not participated in PR in the past year. Participants will be randomly assigned to one of two groups: (1) referral to standard PR (control group), or (2) participation in a 12-week, twice-weekly, group-based TPR program delivered remotely via a dedicated application and video sessions (intervention group).",[28,514,515],"Rehabilitation","Peripheral","2026-06-18",{"date":466,"type":35},{"date":519,"type":23},"2026-07-01",{"date":521,"type":23},"2028-08-01",{"name":523,"class":524},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":55,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":543,"leadSponsor":544,"locationsCount":424},"100644283","tele-pulmonary-rehabilitation-for-patients-with-chronic-lung-diseases-100644283","NCT07666841","Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases","Tele-Pulmonary Rehabilitation to Improve Adherence and Management of Patients With Chronic Lung Diseases","TELE-PRIME","Inclusion Criteria:\n\n1. Patients meeting the Israeli Health Basket criteria for reimbursement of pulmonary rehabilitation (PR), including one of the following conditions:\n\n   * COPD with an FEV1 below 50% or with severe exacerbation (hospitalization) in the previous year or two moderate exacerbations in the previous year.\n   * Interstitial lung disease with an FVC below 80% or a DLCO below 60%.\n   * Bronchiectasis with at least two exacerbations in the past year or at least one hospitalization, and an FEV1 below 80%.\n   * Pulmonary arterial hypertension.\n2. Willingness to initiate a PR or Tele-PR (TPR) programs.\n3. Ability to perform the TPR program or traditional PR activities as assessed by a member of the study team prior to enrollment.\n4. Agree to participate, with signed informed consent.\n\nExclusion Criteria:\n\n1. Uncontrolled comorbidity (e.g uncontrolled congestive heart failure)\n2. Inability to operate the mobile application.\n3. Without a mobile device or computer.\n4. A hospitalization in the 2-months prior to randomization.\n5. Completed PR program in the last 12 months.\n6. Inability to complete 10 repetitions in the 1-minute sit-to-stand test or 5-second single-leg stance\n7. Pregnancy\n8. Inability to provide informed consent due to impaired decision-making capacity, as determined by the study's capacity assessment.",{"count":534,"type":23},90,[57],"Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. The purpose of this study is to evaluate whether a tele-pulmonary rehabilitation (TPR) program can improve the rates of treatment initiation and adherence among patients with chronic lung diseases compared to traditional, center-based pulmonary rehabilitation. Additionally, the study will assess improvements in quality of life, physical symptoms, and safety in both groups.\n\nThis study will enroll 90 patients from two medical centers in Israel (Tel Aviv and Barzilai). Participants will be randomly assigned to one of two groups:\n\n1. The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center.\n2. The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.",[28,514,538,539,540],"Bronchiectasis Adult","Pulmonary Arterial Hypertension (PAH)","Interstitial Lung Disease (ILD)",{"date":466,"type":35},{"date":519,"type":23},{"date":39,"type":23},{"name":523,"class":524},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":553,"targetDuration":4,"studyType":55,"phases":554,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":244},"100641876","phase-2-a-study-of-win378-in-participants-with-moderate-to-severe-copd-sirius-100641876","NCT07646587","A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)","A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease","Sirius","Inclusion Criteria:\n\n* Adults aged 40 to 80 years\n* Post-BD spirometry at screening FEV1\u002FFVC \\\u003C 0.70 and FEV1 30-80% predicted\n* On stable triple inhaled therapy (ICS\u002FLABA\u002FLAMA) for ≥ 3 months\n* Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months\n* Elevated eosinophil count\n* Weight\u002FBMI within allowed range\n\nExclusion Criteria:\n\n* Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD)\n* Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct\n* Clinically significant cardiovascular disease\n* Recent respiratory infection or COPD exacerbation\n* Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period\n* Pregnancy or breastfeeding\n* Smoking or diagnosed substance use disorder\n* Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity",{"count":201,"type":23},[555],"PHASE2","This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)",[28],[65,61,559,560,561,562,563],"Respiratory Disease","Monoclonal Antibody","Inflammation","TSLP","Moderate - Severe","2026-06-16",{"date":566,"type":35},"2026-06-22",{"date":568,"type":35},"2026-06-02",{"date":570,"type":23},"2028-01-07",{"name":572,"class":173},"Windward Bio",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":580,"targetDuration":4,"studyType":55,"phases":582,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":43},"100641713","phase-3-a-phase-3-clinical-trial-to-evaluate-the-safety-and-efficacy-of-hsk39004-inhalation-suspension-in-patients-with-copd-100641713","NCT07658339","A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD","A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002For a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   * Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and\n   * Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;\n2. History of life-threatening acute exacerbation of COPD;\n3. Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);\n4. Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);\n5. Diagnosis of any other clinically significant respiratory disease besides COPD, including but not limited to: alpha-1 antitrypsin deficiency, bronchial asthma, active tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, pulmonary sarcoidosis, or clinically significant idiopathic pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis (except asymptomatic localized bronchiectasis) that, in the opinion of the investigator, poses a safety risk to the participant or may affect the analysis of study result;\n6. Severe or uncontrolled cardiovascular disease or history;\n7. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n8. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n9. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n10. Subjects determined by the investigator to require oxygen therapy;\n11. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)",{"count":581,"type":23},387,[461],"The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).",[28],[586],"PDE3\u002F4","2026-06-15",{"date":566,"type":35},{"date":590,"type":23},"2026-07-11",{"date":592,"type":23},"2027-06-11",{"name":594,"class":173},"Haisco Pharmaceutical Group Co., Ltd.",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":602,"targetDuration":4,"studyType":55,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":43},"100643469","phase-3-a-multicenter-randomized-double-blind-placebo-controlled-parallel-group-phase-iii-study-of-hsk39004-inhalation-powder-for-the-treatment-of-copd-100643469","NCT07583849","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD","A Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Powder in the Treatment of Chronic Obstructive Pulmonary Disease (COPD): a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Design","Inclusion Criteria:\n\n* 1)During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted; 2) The body mass index is within the range of 18 to 30 kg\u002Fm2 (including the threshold value); 3) The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \\[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and\u002For have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\]; 4) During the screening visit (Visit 1):\n\n  * FEV1\u002FFVC after using bronchodilators is \\\u003C0.7;\n  * 30% of the expected value ≤ FEV1 after using bronchodilators \\\u003C 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhalation aerosol for 15 to 30 minutes after use.\n\n    5\\) At the time of screening, the modified British Medical Research Council (mMRC) dyspnea scale score is ≥ 2; 6）Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or former smokers (for example: at least 1 pack per day, for 10 years), or those with a history of exposure to other risk factors.\n\nExclusion Criteria:\n\n* 1） Lactose\u002Fmilk protein (dairy products) intolerance, allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system; 2）Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening; 3) Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening; 4) Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active tuberculosis, lung edema, cystic fibrosis, bronchiectasis, pulmonary nodular disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation); 5) Have a history of or currently have severe cardiovascular diseases, including but not limited to:\n\n  * Screening period NYHA cardiac function grade III\u002FIV (according to the NYHA cardiac function grading standard, see Appendix 1);\n  * Had acute myocardial infarction, unstable angina pectoris\u002Facute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;\n  * Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;\n  * Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate \\> 120 bpm, ventricular tachycardia, bradycardia (ventricular rate \\\u003C 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF \\> 450 ms or female QTcF \\> 470 ms;\n  * Subjects with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit); 6) Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol\u002FL at screening); 7) Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors); 8) Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease\u002Fabnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results; 9) During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations:\n\n    1. The glomerular filtration rate (eGFR) calculated using the CKD-EPI formula is less than 60 mL\u002Fmin\u002F1.73m2;\n    2. Liver function: Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) are more than 2.5 times the upper limit of the normal value; Total bilirubin (TBIL) is more than 1.5 times the upper limit of the normal value.\n\n       10\\) Within 12 months before screening, received lobectomy or lung volume reduction surgery; 11) Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study; 12) Patients determined by the investigator to require oxygen therapy; 13）Have clinically significant apnea that requires the use of a continuous airway positive pressure ventilation (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device;",{"count":603,"type":23},376,[461],"To evaluate the efficacy and safety of a 12-week administration of HSK39004 inhalation powder in clinical trial participants with COPD",[28],"2026-06-08",{"date":609,"type":35},"2026-06-10",{"date":611,"type":35},"2026-05-24",{"date":613,"type":23},"2027-10-30",{"name":594,"class":173},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":622,"targetDuration":4,"studyType":55,"phases":624,"briefSummary":625,"conditions":626,"keywords":627,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":43},"100643596","phase-3-long-term-safety-and-efficacy-of-hsk39004-inhalation-suspension-in-copd-100643596","NCT07634367","Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD","A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002F or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and\u002For before enrollment;\n2. Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III\u002FIV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male \\>450 ms, female \\>470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;\n3. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n4. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n5. Known hypersensitivity to HSK39004 inhalation suspention, salbutamol, or any component of the drug delivery system;\n6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);\n7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;\n9. Subjects determined by the investigator to require oxygen therapy;\n10. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)",{"count":623,"type":23},300,[461],"This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD).",[28],[586],"2026-06-03",{"date":607,"type":35},{"date":631,"type":23},"2026-07-10",{"date":633,"type":23},"2027-12-24",{"name":594,"class":173},"COPD Chronic Obstructive Pulmonary Disease"]