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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39004 Dry Powder Inhaler -0.75mg BID | Experimental | HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39004 Dry Powder Inhaler -0.75mg BID | Drug | HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
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):
Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daishun Liu, M.D. | Contact | +86-13885250001 | liudaishun@gz5055.com | |
| Xianwei Ye, M.D. | Contact | +86-18798619198 | yxw1205@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550002 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Model Description
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Masking Description
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |