The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;
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) <0.7];
Post-bronchodilator FEV1/FVC < 0.7; and
Post-bronchodilator FEV1 ≥ 30% and < 80% of predicted value;
Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;
History of life-threatening acute exacerbation of COPD;
Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);
Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);
Parallel
HSK39004 Inhalation Suspension
DrugDosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks
Placebo control
DrugDosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks
Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12
Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing.
Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24
Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing.
Change from Baseline in Morning trough FEV1 after administration at week 4, 8, 12, 18, 24
Morning trough FEV1 was the last value collected prior to the morning dose. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing.
Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-4h) at Week 4, 8, 12, 18, 24
Average FEV1 AUC0-4h was defined as AUC over 4 hours of the FEV1, divided by 4 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing.
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 12 and 24
The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Score ranging from 0 to 100 and higher scores indicated a worse outcome. Baseline is the score calculated on Day 1.
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