[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625636":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":22,"interventions":29,"overallOfficials":13,"centralContacts":33,"locations":43,"responsibleParty":57,"collaborators":13,"id":59,"slug":13,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":13,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":13,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":13,"overallStatus":77,"whyStopped":13,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment-emergent adverse event (TEAE) incidence","The incidence of treatment-emergent adverse events (TEAEs), assessed through vital signs, physical examinations, laboratory tests, 12-lead ECG parameters, and detailed adverse event monitoring.","From week 1 to week 53",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","Model Description","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","Masking Description",[23],{"label":24,"type":25,"description":26,"interventionNames":27},"HSK39004 Dry Powder Inhaler -0.75mg BID","EXPERIMENTAL","HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day",[28],"Drug: HSK39004 Dry Powder Inhaler -0.75mg BID",[30],{"type":31,"name":24,"description":26,"armGroupLabels":32,"otherNames":13},"DRUG",[24],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":13,"email":38},"Daishun Liu, M.D.","CONTACT","+86-13885250001","liudaishun@gz5055.com",{"name":40,"role":36,"phone":41,"phoneExt":13,"email":42},"Xianwei Ye, M.D.","+86-18798619198","yxw1205@163.com",[44],{"facility":45,"status":13,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":13},"Guizhou Provincial People's Hospital","Guiyang","Guizhou","550002","China","CN",{"type":52,"coordinates":53},"Point",[54,55],106.71667,26.58333,{"lat":55,"lon":54},{"type":58,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":69,"type":70},300,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76],"Chronic Obstructive Lung Disease (COLD)","NOT_YET_RECRUITING","2026-02-23",{"date":80,"type":81},"2026-02-25","ACTUAL",{"date":83,"type":70},"2026-03",{"date":85,"type":70},"2027-08",{"name":5,"class":6},1]