NCT00551382

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Muntelukast	Tablets or granules; 4 mg once a day for 12 weeks
DRUG	Placebo	Look alike tablets or granules 1 per day for 12 weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2007-10-31
• Last updated: 2010-03-17

Locations

3 sites across 1 country: Israel