NCT07108699

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Dry Powder Inhaler in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler compared with the placebo in the treatment of Chinese patients with COPD.

Detailed description

o evaluate the efficacy, PK characteristics and safety of different doses of HSK39004 Dry Powder Inhaler in patients with COPD under background treatment (single bronchodilator/double bronchodilator, with the combined use of ICS not exceeding 25% of the total enrolled population)

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	HSK39004 Dry Powder Inhaler-0.75mg	HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
DRUG	HSK39004 Dry Powder Inhaler-1.5mg	HSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day
DRUG	HSK39004 Dry Powder Inhaler Simulant	HSK39004 Dry Powder Inhaler Simulants, administered via oral inhalation, 1 tablet each time, twice daily

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-08-30
• Completion: 2026-09-30
• First posted: 2025-08-07
• Last updated: 2026-04-08

Locations

1 site across 1 country: China