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

March 16, 2010 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Lod, Israel
        • Recruiting
        • Kupat Cholim Clalit
        • Contact:
          • Al Garushi
        • Principal Investigator:
          • Al Garushi, MD
      • Ramla, Israel
        • Recruiting
        • Kupat Cholim Clalit
        • Principal Investigator:
          • Zachi Lotem
      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf Harofeh
        • Contact:
          • Berkovitch
          • Phone Number: 97289779152
        • Principal Investigator:
          • Mati Berkovitch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Muntelukast
Tablets or granules; 4 mg once a day for 12 weeks
Other Names:
  • Singulair
Placebo Comparator: B
Drug: Placebo
Look alike tablets or granules 1 per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number and duration of URI episodes
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome 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.
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Mati Berkovitch, MD, Assaf-Harofeh Medical Center
  • Principal Investigator: Eran Kozer, MD, Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2010

Last Update Submitted That Met QC Criteria

March 16, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142/06
  • 20060504(142/06)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe