Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD

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).

Key Inclusion Criteria: 1. 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female; 2. 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/ 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 / forced vital capacity (FVC) \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; 3. 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; 4. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases/abnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis; 5. Known hypersensitivity to HSK39004 inhalation suspention, salbutamol, or any component of the drug delivery system; 6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1); 7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening; 8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion; 9. Subjects determined by the investigator to require oxygen therapy; 10. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)