We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00551382
Recruitment Status : Unknown
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : October 31, 2007
Last Update Posted : March 17, 2010
Merck Sharp & Dohme Corp.
Information provided by:
Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infection Drug: Muntelukast Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Study Start Date : November 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The number and duration of URI episodes [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551382

Contact: Mati Berkovitch, MD 972 8 9779152 mberkovitch@asaf.health.gov.il
Contact: Eran Kozer, MD 972 8 9778131 erank@asaf.health.gov.il

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

Responsible Party: Berkovitch M, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00551382     History of Changes
Other Study ID Numbers: 142/06
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: March 17, 2010
Last Verified: March 2010

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
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action