CTRI/2026/02/102817招募中4 期
A Phase IV study to evaluate safety and efficacy of FDC of Glycopyrronium 12.5 mcg & Formoterol Fumarate 6 mcg Inhaler in patients with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 9
研究概览
简要总结
A Phase IV open label, prospective, non-comparative, multicentre, interventional study to evaluate safety and efficacy of FDC of Glycopyrronium & Formoterol Fumarate Inhaler (12.5 mcg + 6 mcg) in patients with Chronic Obstructive Pulmonary Disease (COPD). The study will be conducted in 100 participants in India. The study will primarily evaluate the safety and tolerability of FDC of Glycopyrronium & Formoterol Fumarate Inhaler through assessment of adverse events including Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs). Additionally the study will also evaluate efficacy of the formulation as maintenance treatment in patients with COPD
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
- •1 A voluntarily given written, signed, and dated informed consent from subjects 2 Subjects of either gender 40 years or above 3 Subjects with a documented history of COPD based on spirogram and in compliance to the GOLD 2025 guidelines 4 Subjects with Post-bronchodilator FEV1 greater than or equal to 30% of the predicted normal value and Post-bronchodilator FEV1/FVC ratio of less than 0.7 5 Subjects with CAT score greater than or equal to 10 6 Subject with current or past cigarette smoking history or exposure to noxious stimuli 7 Subject should be able to correctly use the pressurised metered dose inhaler pMDI.
排除标准
- •History of hypersensitivity to glycopyrronium or formoterol fumarate or any of its components.
- •Subjects receiving dual therapy (LABA + LAMA), 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.
- •Clinically significant neurologic, cardiovascular, hepatic, renal, endocrine, pulmonary (post-tuberculosis fibrosis, pulmonary fibrotic disease, pulmonary arterial hypertension), hematologic, psychiatric, or other medical illness that will interfere with participation in this study.
研究者
Dr Jaideep Gogtay
Cipla Limited
研究点 (9)
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