CTRI/2025/12/099667招募中4 期
A Phase IV study to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) triple therapy delivered through pressurized metered dose inhaler [pMDI] in patients with Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 100
- 试验地点
- 10
研究概览
简要总结
All patients willing to participate in the study will be required to give a written informed consent in the language understood by him/her. Patients will require a confirmed documented diagnosis of COPD through spirometry and satisfying the eligibility criteria.Patients will be enrolled. Safety and efficacy assessments will be performed at screening, baseline, week 6 and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •A voluntarily given, written, signed, and dated informed consent from subjects.
- •Subjects of either gender 40 years or above.
- •Subjects with a documented history of COPD based on spirogram.
- •Post-bronchodilator FEV1 greater than or equal to 30 percent and less than or equal to 80 percent of the predicted normal value.
- •Post-bronchodilator FEV1/FVC ratio of less than 0.7.
- •Subjects with CAT score greater than or equal to 10.
- •Current or ex-smoker of at least 10 pack years of cigarette/ bidi smoking or subjects who had exposure to noxious stimuli.
排除标准
- •History of hypersensitivity to glycopyrronium or formoterol or budesonide or any of its components.
- •Subjects receiving triple therapy (ICS+LABA+LAMA) (fixed dose or free combination) for COPD within 3 months from screening.
- •Subjects with hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening.
- •Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening
- •Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening.
- •Clinically significant ECG abnormality (QTcF greater than 500msec) at screening.
- •History of clinically significant bladder neck obstruction or urinary retention
- •History of uncontrolled glaucoma.
- •History of uncontrolled diabetes mellitus.
- •Female who is pregnant or lactating or planning to be pregnant
- •Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
研究者
Dr Jaideep Gogtay
Cipla Limited
研究点 (10)
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