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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

To evaluate the efficacy and safety of a 12-week administration of HSK39004 inhalation powder in clinical trial participants with COPD

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HSK39004 Dry Powder Inhaler Simulant
  • HSK39004 Dry Powder Inhaler-0.75mg

Treatment groups

376 Participants
are divided into 2 treatment groups