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ACTIVE NOT RECRUITING
NCT07140328
PHASE2

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-24

Completion Date

2026-08

Last Updated

2026-04-08

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; 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 ;

Locations (1)

Jiangsu Provincial People's Hospital

Nanchang, Jiangsu, China