NCT07140328

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension 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 and HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• 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 and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.

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； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
DRUG	HSK39004 Dry Powder Inhaler -1.5mg BID	HSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
DRUG	HSK39004 Inhalation Suspension -3mg BID	HSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； And HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ；
DRUG	HSK39004 Placebo	HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；

Timeline

• Start date: 2025-04-24
• Primary completion: 2025-07-10
• Completion: 2026-08-01
• First posted: 2025-08-24
• Last updated: 2026-04-08

Locations

1 site across 1 country: China