A clinical trial to study the effects of two drugs, Zileuton extended-release tablets and Montelukast sodium 10 mg tablets in patients with bronchial asthma.
- Conditions
- Health Condition 1: null- Bronchial asthmaHealth Condition 2: J459- Other and unspecified asthma
- Registration Number
- CTRI/2009/091/000639
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
1.Pregnancy and/or lactation
2.Patients with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment
3.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
4.Patients with liver dysfunction i.e., active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal
5.Patients with any other clinically significant illness
6.Patients with a history of hypersensitivity to any of the components of the study medications
7.Patients with any other serious concurrent illness or malignancy
8.Patients with continuing history of alcohol and / or drug abuse
9.Participation in another clinical trial in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of improvement in mean PEFR at each visit and at the end of the study as compared to baselineTimepoint: 4,8 & 12 weeks
- Secondary Outcome Measures
Name Time Method 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 baselineTimepoint: 4,8 & 12 weeks