Real World Evidence on safety and effectiveness of single inhaler triple-therapy(glycopyrrolate/formoterol fumarate/budesonide) in patients with COPD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Adverse & Serious Adverse events during the study period
研究概览
简要总结
This study is being carried out to understand the safety and effectivenessof single inhaler triple- therapy Glycopyrrolate (25 mcg) + Formoterol Fumarate(12 mcg) + Budesonide (400 mcg) [GFB DPI] and Glycopyrrolate (9 mcg) +Formoterol Fumarate(4.8mcg) +Budesonide(160mcg)[GFB MDI] -Forglyn plus inhaler in patients withestablished clinical history of COPD amongst the Indian population. There is nodata of this combination in real world setting among Indian patients with COPD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible for single inhaler triple therapy (LABA + LAMA + ICS) as per clinician’s discretion Gives signed written informed consent to participate. For Female patients A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal) For females with childbearing potential, who agrees for contraception throughout.
- •from Visit 1 (Screening) till 1 month after the final visit).
排除标准
- 未提供
结局指标
主要结局
Adverse & Serious Adverse events during the study period
时间窗: Baseline, 4 weeks & 24 weeks
Spirometry measures
时间窗: Baseline, 4 weeks & 24 weeks
Change in COPD Assessment Test
时间窗: Baseline, 4 weeks & 24 weeks
Change in modified Medical Research Council Dyspnoea Scale
时间窗: Baseline, 4 weeks & 24 weeks
Change in Clinical COPD Questionnaire
时间窗: Baseline, 4 weeks & 24 weeks
Number of severe exacerbations needing hospitalizations
时间窗: Baseline, 4 weeks & 24 weeks
Use of rescue medications (SABA pMDI) during the study period
时间窗: Baseline, 4 weeks & 24 weeks
次要结局
- NA(NA)