CTRI/2009/091/000118已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck Co Inc
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Percentage of asthma-control days over the 6-month treatment period
研究概览
简要总结
Number of Indian subjects proposed for enrollment in this global study is 30 Date of first enrollment (India)- 29 Jun 2009
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day.
排除标准
- •Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
结局指标
主要结局
Percentage of asthma-control days over the 6-month treatment period
时间窗: Time Frame: 6 months [ Designated as safety issue: No ]
次要结局
- AM Peak Expiratory Flow Rate (PEFR) and daytime symptom score over the 6-month treatment period(Time Frame: 6 months [ Designated as safety issue: No ])
研究者
研究点 (2)
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