A randomized, open label, active-controlled, parallel-group, multicenter, Phase III study to evaluate efficacy, safety, and tolerability of Revefenacin inhalationsolution 175 mcg versus Tiotropium dry powder for inhalation 18 mcg in subjects with Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 362
- 试验地点
- 20
研究概览
简要总结
This will be a multicenter, randomized study including 362 subjects with COPD. Subjects will receive study drug for 12 weeks. Study drug (Revefenacin inhalation solution 175 mcg OD)will be administered using a standard jet nebulizer and compressor via a mouthpiece. Comparator drug (Tiotropium 18mcg OD) will be administered via dry powder inhaler. Subjects will berandomly assigned in a 1:1 ratio, as per randomization code. Subjects will have approximately 6 visits (encompassing a screening period of up to 15 days and a treatment period of 12weeks). Adverse events, concomitant medication use, and rescue medication use since the previous visit will be reviewed at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Male and female subjects aged 40 years and above with documented diagnosis of COPD based on Global Initiative for Chronic Obstructive LungDisease guideline 2025
- •Subject has a current or past cigarette smoking history or exposure to noxious stimuli
- •Subjects has a post-ipratropium FEV1/FVC ratio of less than 0.7 and post-ipratropium FEV1 of less than 80% to Greater than and equal to 30% ofpredicted normal and an absolute FEV1 of at least 700 ml at screening.
- •Subjects with CAT score greater than 10.
排除标准
- •History of hypersensitivity to similar class of drugs or to any of the excipients of the formulations.
- •Subjects who have previously taken revefenacin.
- •Subjects with history of myocardial infarction or unstable angina within the previous 6 months, unstable or life-threatening cardiac arrhythmia requiringintervention within the previous 3 months.
- •Subject with NYHA Class IV heart failure prior to the start of the study or exhibited an abnormal and clinically significant 12-lead ECG (QTcF greaterthan 500msec) at screening.
- •Subjects with unstable cardiovascular disease including history of one or more of pre-specified cardiac disorders such as ischemic heart disease,cerebrovascular disease, peripheral arterial disease, heart failure and/or hypertension.
- •Any medical condition precluding use of inhaled anticholinergics, including paradoxical bronchospasm, narrow-angle glaucoma, or symptomatic prostatichypertrophy or bladder outlet obstruction, urinary retention.
- •Subjects with concomitant clinically significant respiratory disease, other than COPD as determined by the Investigator such as asthma, bronchiectasis,pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis, or a recent history of respiratory tract infection within 6 weeks.
研究者
Dr Jaideep Gogtay
Cipla Limited
