NCT07658339尚未招募3 期
A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;
- •History of life-threatening acute exacerbation of COPD;
- •Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);
- •Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);
- •Diagnosis of any other clinically significant respiratory disease besides COPD, including but not limited to: alpha-1 antitrypsin deficiency, bronchial asthma, active tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, pulmonary sarcoidosis, or clinically significant idiopathic pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis (except asymptomatic localized bronchiectasis) that, in the opinion of the investigator, poses a safety risk to the participant or may affect the analysis of study result;
- •Severe or uncontrolled cardiovascular disease or history;
- •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;
- •History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
- •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 Inhalation Suspension
Experimental
3 mg BID
干预措施: HSK39004 Inhalation Suspension (Drug)
Placebo control
Placebo Comparator
BID
干预措施: Placebo control (Drug)
结局指标
主要结局
Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12
时间窗: Baseline (pre-dose on Day 1) and 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.
次要结局
- Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24(Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24)
- Change from Baseline in Morning trough FEV1 after administration at week 4, 8, 12, 18, 24(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(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(Day1, Weeks 12 and 24)
- Treatment-emergent adverse event (TEAE) incidence(From week 1 to week 25)
研究者
研究点 (1)
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