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NCT07658339
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 387
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Location: Peking University Third Hospital Beijing
Summary
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).
Eligibility Criteria
Key Inclusion Criteria:
1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;
2. 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) \
Source: ClinicalTrials.gov (NCT07658339). StuddyBuddy aggregates publicly available trial information.
