NCT07425210尚未招募2 期
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)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse event (TEAE) incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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);
研究组 & 干预措施
HSK39004 Dry Powder Inhaler -0.75mg BID
Experimental
HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
干预措施: HSK39004 Dry Powder Inhaler -0.75mg BID (Drug)
结局指标
主要结局
Treatment-emergent adverse event (TEAE) incidence
时间窗: From week 1 to week 53
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.
次要结局
未报告次要终点
研究者
研究点 (1)
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