To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.
During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
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 exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7];
FEV1/FVC after using bronchodilators is <0.7;
30% of the expected value ≤ FEV1 after using bronchodilators < 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.
Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening;
Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening;
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);
Screening period NYHA cardiac function grade III/IV (according to the NYHA cardiac function grading standard, see Appendix 1);
Parallel
HSK39004 Dry Powder Inhaler -0.75mg BID
DrugHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
HSK39004 Dry Powder Inhaler -1.5mg BID
DrugHSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
HSK39004 Inhalation Suspension -3mg BID
DrugHSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； And HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ；
HSK39004 Placebo
DrugHSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
1. The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve representing the change in FEV1 from baseline to 12 hours after administration)
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