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NOT YET RECRUITING
NCT07425210
PHASE2

Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.

Official title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03

Completion Date

2027-08

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

HSK39004 Dry Powder Inhaler -0.75mg BID

HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day

Locations (1)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China