Clinical trial NCT00551382: Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study
Official title: Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Upper Respiratory Tract Infection
Keywords: Montelukast
Upper respiratory tract infection
leukotriene
Children
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-10-31
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The number and duration of URI episodes
timeFrame: 3 month
Secondary outcomes:
measure: 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.
timeFrame: 3 month
Other outcomes:
Locations:
city: Lod
country: Israel
facility: Kupat Cholim Clalit
city: Ramla
country: Israel
facility: Kupat Cholim Clalit
city: Zerifin
country: Israel
facility: Assaf Harofeh
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Mati Berkovitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: Eran Kozer, MD
role: PRINCIPAL_INVESTIGATOR
References: