Upper Respiratory Tract Infection Clinical Trial
Official title:
Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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