[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625636":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":29,"responsibleParty":43,"collaborators":18,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":18,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":18,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":18,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HSK39004 Dry Powder Inhaler -0.75mg BID","EXPERIMENTAL","HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day",[13],"Drug: HSK39004 Dry Powder Inhaler -0.75mg BID",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Daishun Liu, M.D.","CONTACT","+86-13885250001","liudaishun@gz5055.com",{"name":26,"role":22,"phone":27,"phoneExt":18,"email":28},"Xianwei Ye, M.D.","+86-18798619198","yxw1205@163.com",[30],{"facility":31,"status":18,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":18},"Guizhou Provincial People's Hospital","Guiyang","Guizhou","550002","China","CN",{"type":38,"coordinates":39},"Point",[40,41],106.71667,26.58333,{"lat":41,"lon":40},{"type":44,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100625636","phase-2-long-term-safety-and-efficacy-of-hsk39004-dry-powder-inhaler-in-copd-100625636",false,"NCT07425210","Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD","A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With 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. 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 powder, 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);","ALL","40 Years","80 Years",{"count":56,"type":57},300,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.",[63],"Chronic Obstructive Lung Disease (COLD)","NOT_YET_RECRUITING","2026-02-23",{"date":67,"type":68},"2026-02-25","ACTUAL",{"date":70,"type":57},"2026-03",{"date":72,"type":57},"2027-08",{"name":5,"class":6},1]