CTRI/2009/091/000639已完成3 期
An open label, comparative, multicentric study to assess the efficacy and safety of Zileuton extended-release tablets in comparison with Montelukast sodium tablets in patients suffering from bronchial asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- The degree of improvement in mean PEFR at each visit and at the end of the study as compared to baseline
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of Zileuton 600 mg extended-release tablets and Montelukast sodium 10 mg tablets for 12 weeks in 200 patients with bronchial asthma that will be conducted in four centers in India. The primary outcome measures will be the degree of improvement in mean PEFR at each visit and at the end of the study as compared to baseline. The date of enrollment of first patient is 06/06/2009 and 200 patients are proposed to be enrolled in this trial to be conducted only in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between 18-65 years of age 2.Patients with an established diagnosis of mild to moderate chronic persistent bronchial asthma 3.Informed consent of the patient/relative.
排除标准
- •1.Pregnancy and/or lactation2.Patients with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment3.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment4.Patients with liver dysfunction i.e., active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal5.Patients with any other clinically significant illness6.Patients with a history of hypersensitivity to any of the components of the study medications7.Patients with any other serious concurrent illness or malignancy8.Patients with continuing history of alcohol and / or drug abuse9.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of improvement in mean PEFR at each visit and at the end of the study as compared to baseline
时间窗: 4,8 & 12 weeks
次要结局
- The degree of improvement in the overall symptoms (cough, wheeze, chest tightness, and shortness of breath) as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baseline(4,8 & 12 weeks)
研究者
研究点 (6)
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