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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• The number and duration of URI episodes
  • Time Frame: 3 month
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 3 month
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Assaf-Harofeh Medical Center Other

Overall Clinical Trial Officials and Contacts

Mati Berkovitch, MD Principal Investigator Assaf-Harofeh Medical Center  

Overall Contact: Mati Berkovitch, MD 972 8 9779152 mberkovitch@asaf.health.gov.il

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00551382

Study ID Number: 142/06

ClinicalTrials.gov Identifier: NCT00551382

Health Authority: Israel: Ministry of Health