Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD
A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
300
1 country
1
Brief Summary
This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
February 25, 2026
February 1, 2026
1.3 years
February 13, 2026
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-emergent adverse event (TEAE) incidence
The incidence of treatment-emergent adverse events (TEAEs), assessed through vital signs, physical examinations, laboratory tests, 12-lead ECG parameters, and detailed adverse event monitoring.
From week 1 to week 53
Study Arms (1)
HSK39004 Dry Powder Inhaler -0.75mg BID
EXPERIMENTALHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
Interventions
HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
Eligibility Criteria
You may qualify if:
- Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;
- Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and/or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) \<0.7\];
- At screening visit (Visit 1):
- Post-bronchodilator FEV1/FVC \< 0.7; and
- Post-bronchodilator FEV1 ≥ 30% and \< 80% of predicted value;
- Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;
You may not qualify if:
- Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and/or before enrollment;
- Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III/IV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male \>450 ms, female \>470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;
- History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;
- Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases/abnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;
- Known hypersensitivity to HSK39004 inhalation powder, salbutamol, or any component of the drug delivery system;
- Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);
- History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
- Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;
- Subjects determined by the investigator to require oxygen therapy;
- Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Masking Description
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02