Effects of Montelukast in Children With Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium; Drug: placebo

• Registration Number: NCT00675285
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-08
• Last Update Submitted: 2008-05-08
• Study First Posted: 2008-05-09
• Last Update Posted: 2008-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
• exhaled nitric oxide (NO) >20 PPB at visit 2
• symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
• no regular medication, inhaled short-acting beta-2 agonists for symptom relief

Exclusion Criteria

• Patient is hospitalized
• Patient has FEV1 < 80% predicted on visit 1
• Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
• upper respiratory infection in the previous 3 weeks
• treatment with glucocorticoids or LTRAs in the previous 4 weeks
• treatment with inhaled glucocorticoids for more than 4 weeks in the previous year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
post-treatment fractional exhaled nitric oxide

Secondary Outcome Measures

Name	Time	Method
fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
post-treatment FEV1
post-treatment FVC
post-treatment FEV1/FVC
post-treatment FEF25%-75%
FEV1 2 weeks after montelukast withdrawal
FVC 2 weeks after montelukast withdrawal
FEV1/FVC 2 weeks after montelukast withdrawal
FEF25%-75% 2 weeks after montelukast withdrawal
asthma exacerbation rate

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy