NCT00675285

Effects of Montelukast in Children With Asthma

Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	montelukast sodium	one tablet 5 mg once/day for 4 weeks
DRUG	placebo	one tablet 5 mg once/day for 4 weeks

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-05-09
• Last updated: 2008-05-09

Locations

1 site across 1 country: Italy