Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)

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• 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/m2 (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/or have a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) after using bronchodilators is less than 0.7]; 4) During the screening visit (Visit 1):
• FEV1/FVC is less than 0.7 after using bronchodilators;
• 30% of the expected value ≤ FEV1 < 80% of the expected value after using bronchodilators; Note: Using bronchodilators refers to inhaling 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhaler for 15 to 30 minutes.
• 5) At the time of screening, the modified British Medical Research Council (mMRC) dyspnea scale score is ≥ 2; 6) Before screening, the subjects have been using bronchodilator drugs for stabilization for at least 1 month, and agree to continue using them during the study without changing the dosage and type of medication; The prohibited/limited drugs and time intervals before screening are detailed in Chapters 5.9.2 and 5.9.3; 1) Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation; 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:
• Screening period NYHA cardiac function grade III/IV (according to the NYHA cardiac function grading standard, see Appendix 1);
• Had acute myocardial infarction, unstable angina pectoris/acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;