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
- Other and unspecified asthma,
- Registration Number
- CTRI/2009/091/000639
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 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.
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 baseline 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 baseline 4,8 & 12 weeks
Trial Locations
- Locations (6)
ASHRAI ASSOCIATES, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
B.J. Medical College & Civil Hospital, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Chest & TB Hospital, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr. S. N. Medical College, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Gyan Pushp Research Centre for Chest & Allergy Disease, Indore.
🇮🇳Indore, MADHYA PRADESH, India
Mahatma Gandhi National Institute of Medical Sciences, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
ASHRAI ASSOCIATES, Ahmedabad🇮🇳Ahmadabad, GUJARAT, IndiaDr. Tushar B. PatelPrincipal investigator079-26579550drtusharpatel@yahoo.com