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

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: Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: Muntelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mati Berkovitch, MD; Phone Number: 972 8 9779152; Email: mberkovitch@asaf.health.gov.il
• Study Contact Backup: Name: Eran Kozer, MD; Phone Number: 972 8 9778131; Email: erank@asaf.health.gov.il

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

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	3 month

Collaborators and Investigators

• 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

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: Children; leukotriene; Montelukast; Upper respiratory tract infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 142/06; 20060504(142/06)