Effects of Montelukast in Children With Asthma

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: montelukast sodium<br>* one tablet 5 mg once/day for 4 weeks<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* one tablet 5 mg once/day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-treatment fractional exhaled nitric oxide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway inflammation, childhood asthma, fractional exhaled nitric oxide, leukotriene receptor antagonists, lung function