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The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39004 Inhalation Suspension | Experimental | 3 mg BID |
|
| Placebo control | Placebo Comparator | BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39004 Inhalation Suspension | Drug | Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg,Twice Daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 | Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. | Baseline (pre-dose on Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24 | Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. | Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24 |
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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 | |
|---|---|---|---|---|
| Yongchang Sun, Doctor | Contact | (+86)13910979132 | suny@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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| Placebo control | Drug | Dosage Formulation: Placebo Inhalation suspension Dosage 0mg,Twice Daily for 24 weeks |
|
| Change from Baseline in Morning trough FEV1 after administration at week 4, 8, 12, 18, 24 |
Morning trough FEV1 was the last value collected prior to the morning dose. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. |
| Baseline (pre-dose on Day 1) and week 4, 8, 12, 18, 24 |
| Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-4h) at Week 4, 8, 12, 18, 24 | Average FEV1 AUC0-4h was defined as AUC over 4 hours of the FEV1, divided by 4 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. | Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24 |
| Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 12 and 24 | The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Score ranging from 0 to 100 and higher scores indicated a worse outcome. Baseline is the score calculated on Day 1. | Day1, Weeks 12 and 24 |
| 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 25 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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