Effect of Montelukast in Asthma in Children

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is 9 month, placebo-controlled, double blind, randomised trial using the oral leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate asthma age 6-14 year old, sensitive to house dust mite. There are two study groups: montelukast group 80 patients and placebo group 80 patients. All patients will receive budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children with not fully control asthma had administered 100 mcg higher dose of budesonide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: Budesonide; Montelukast

Criteria

Inclusion Criteria:

• Children with bronchial asthma

Exclusion Criteria:

• All other serious diseases