RecruitingPhase 2NCT07140328

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)


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

50 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HSK39004 Dry Powder Inhaler -0.75mg BID, a drug called HSK39004 Dry Powder Inhaler -1.5mg BID, and others for people with chronic obstructive lung disease (cold). The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK39004 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 ;

DRUGHSK39004 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 ;

DRUGHSK39004 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 ;

DRUGHSK39004 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

View Full Details on ClinicalTrials.gov

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NCT07140328


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