Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.

Study Overview
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Brief Summary
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This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.

Detailed Description
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This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period. After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test. Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.

Official Title
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A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma

Conditions
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Mild Persistent Asthma

Intervention / Treatment
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* Drug: Montelukast to placebo
* Drug: Placebo to montelukast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children diagnosed with mild persistent asthma patients based on the GINA guidelines children old enough to cooperate in performing pulmonary function testing legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB children with no respiratory symptoms 4 weeks prior to the beginning of the study children without chronic respiratory symptoms. Exclusion Criteria: presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy. use of systemic corticosteroids in past 4 weeks. admission or visit of the emergency department in past 4 weeks.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: montelukast to placebo<br>14 days | Drug: Montelukast to placebo<br>* Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks<br>* Other names: SINGULAIR 4mg or 5mg;|
| No Intervention: Washout<br>14 days | |
| Active Comparator: Placebo to montelukast<br>14 days | Drug: Placebo to montelukast<br>* Subjects will receive matching placebo. Each treatment period consists of 2 weeks<br>* Other names: SINGULAIR 4mg or 5mg matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5) | Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5) | Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator | Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10) | Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function of FEV1 Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function of FEV1/FVC Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator | up to 2 weeks | 
| Baseline Lung Function in MMEF | Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change (%) of FEV1 After the Bronchodilator | Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100 | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukotriene Antagonists, Bronchodilator response