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

Phase 3

• Conditions: Upper Respiratory Tract Infection
• Interventions: Drug: Muntelukast; Drug: Placebo

• Registration Number: NCT00551382
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-10-31
• Study Start: 2007-11
• Primary Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-17
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Muntelukast	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
The number and duration of URI episodes	3 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Kupat Cholim Clalit; 🇮🇱 Ramla, Israel

Assaf Harofeh; 🇮🇱 Zerifin, Israel