NCT07425210

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Lung Disease (COLD)

Interventions

Type	Name	Description
DRUG	HSK39004 Dry Powder Inhaler -0.75mg BID	HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2026-02-20
• Last updated: 2026-02-25

Locations

1 site across 1 country: China