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);