CTRI/2025/06/089209尚未招募3 期
A Prospective, Randomized, Double-blind, Parallel, Active-controlled, Multicentre, Phase III clinical trial to assess the efficacy and safety of Glycopyrronium and Indacaterol inhalation as compared to Vilanterol and Glycopyrronium inhalation in patients with Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 274
- 试验地点
- 5
- 主要终点
- Change from baseline in trough FEV1
研究概览
简要总结
A Prospective, Randomized,Double-blind, Parallel, Active-controlled, Multicentre, Phase III clinicaltrial to assess the efficacy and safety of Glycopyrronium and Indacaterolinhalation as compared to Vilanterol and Glycopyrronium inhalation in patientswith Chronic Obstructive Pulmonary Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of either gender between 40-65 years of age (both inclusive)
- •Participants who are current/ex-smokers
- •Participants diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a.
- •Post-bronchodilator FEV1/FVC ratio less than 0.7; b.
- •Post-bronchodilator FEV1, greater than or equals to 30 percent to less than 80 percent predicted
- •Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
- •COPD Assessment Test (CAT) score greater than or equals to 10 at screening
- •Participants literate enough to fill the diary card.
排除标准
- •Participants suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- •Participants with known hypersensitivity to indacaterol, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
- •Participants with known alpha 1 antitrypsin deficiency
- •COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •Participants hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- •Participants who required long-term oxygen therapy (greater than or equals to 12 hours/day) within 4 weeks prior to the screening or during the screening period
- •Participants with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder neck obstruction or urinary retention.
- •Participants with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •Participants with hepatic dysfunction (serum transaminases greater than or equals to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater than or equals to 2.5 mg/dl) at screening
- •Participants who have used prohibited medications
- •Participants with continuing history of alcohol and/or drug abuse
- •Pregnant or Lactating females; or female participants of childbearing potential or male participants unwilling to use effective contraception during and 1 month after completion of the study.
- •Male participants who are unwilling to not donate sperm for the purpose of reproduction.
- •Participant participated in any clinical trial in the past 3 months
- •Any other reason for which the investigator feels that the participant should not participate.
结局指标
主要结局
Change from baseline in trough FEV1
时间窗: At week 12
次要结局
- 1. Change from baseline in trough FEV1(2. Change from baseline in trough FVC)
研究者
研究点 (5)
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