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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Merck Sharp & Dohme Corp.
Information provided by:
Assaf-Harofeh Medical Center Identifier:
First received: October 30, 2007
Last updated: March 16, 2010
Last verified: March 2010

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.

Condition Intervention Phase
Upper Respiratory Tract Infection
Drug: Muntelukast
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • The number and duration of URI episodes [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: November 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Muntelukast
Tablets or granules; 4 mg once a day for 12 weeks
Other Name: Singulair
Placebo Comparator: B Drug: Placebo
Look alike tablets or granules 1 per day for 12 weeks


Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00551382

Contact: Mati Berkovitch, MD 972 8 9779152
Contact: Eran Kozer, MD 972 8 9778131

Kupat Cholim Clalit Recruiting
Lod, Israel
Contact: Al Garushi         
Principal Investigator: Al Garushi, MD         
Kupat Cholim Clalit Recruiting
Ramla, Israel
Principal Investigator: Zachi Lotem         
Assaf Harofeh Recruiting
Zerifin, Israel, 70300
Contact: Berkovitch    97289779152      
Principal Investigator: Mati Berkovitch, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Mati Berkovitch, MD Assaf-Harofeh Medical Center
Principal Investigator: Eran Kozer, MD Assaf-Harofeh Medical Center
  More Information

Responsible Party: Berkovitch M, Assaf Harofeh Medical Center Identifier: NCT00551382     History of Changes
Other Study ID Numbers: 142/06  20060504(142/06) 
Study First Received: October 30, 2007
Last Updated: March 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
Upper respiratory tract infection

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Asthmatic Agents
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 30, 2016