Overview

Effects of Montelukast in Children With Asthma

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma. A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo. A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.
Phase:
Phase 3
Details
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Montelukast