Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study

Study Overview
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Brief Summary
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Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable. Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI. Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.

Official Title
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Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children

Conditions
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Upper Respiratory Tract Infection

Intervention / Treatment
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* Drug: Muntelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 1 to 5 years old without significant health problem. Exclusion Criteria: A previous history of wheezing (requiring treatment with bronchodilators in the last 3 month or more than one treatment in the last year) Hospital admission due to reactive air way disease Prophylactic use of montelukast or steroids Chronic cardiac or respiratory disease Presence of acute respiratory tract infection within the 7 days before consideration for the study History of allergic Rhinitis Children who are receiving chronic medications of any kind Known allergy to montelukast Inability to get an informed consent from a legal guardian.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Muntelukast<br>* Tablets or granules; 4 mg once a day for 12 weeks<br>* Other names: Singulair;|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Look alike tablets or granules 1 per day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and duration of URI episodes |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug. |  | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Montelukast, Upper respiratory tract infection, leukotriene, Children