A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD

Who cannot join

• 1） Lactose/milk protein (dairy products) intolerance, allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system; 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;
• Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;
• Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate > 120 bpm, ventricular tachycardia, bradycardia (ventricular rate < 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF > 450 ms or female QTcF > 470 ms;
• Subjects with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit); 6) Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening); 7) Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors); 8) Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease/abnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results; 9) During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations: