Health Condition 1: null- Bronchial asthma Health Condition 2: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Zileuton 600 mg extended-release tablets: two tablets twice in a day within 1 hour after morning and evening meals for 12 weeks
Control Intervention1: Montelukast sodium 10 mg tablets:
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Outcome results
None listed