Upper Respiratory Tract Infection
Conditions
Keywords
Montelukast, Upper respiratory tract infection, leukotriene, Children
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.
Interventions
DRUGMuntelukast
Tablets or granules; 4 mg once a day for 12 weeks
DRUGPlacebo
Look alike tablets or granules 1 per day for 12 weeks
Sponsors
Merck Sharp & Dohme LLC
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and duration of URI episodes | 3 month |
Secondary
| Measure | 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 |
Countries
Israel
Contacts
Primary ContactMati Berkovitch, MD
Backup ContactEran Kozer, MD
Outcome results
None listed