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

NCT07140328 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-08

No results posted yet for this study

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

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 ；

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2025-07-10
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140328 on ClinicalTrials.gov