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

NCT ID: NCT00551382

Last Updated: 2010-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-06-30

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.

Conditions

Upper Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

A

Group Type: EXPERIMENTAL

Muntelukast

Intervention Type: DRUG

Tablets or granules; 4 mg once a day for 12 weeks

B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Look alike tablets or granules 1 per day for 12 weeks

Interventions

Muntelukast

Tablets or granules; 4 mg once a day for 12 weeks

Intervention Type: DRUG

Placebo

Look alike tablets or granules 1 per day for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Singulair

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh Medical Center

Principal Investigators

Mati Berkovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Eran Kozer, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

Kupat Cholim Clalit

Lod, , Israel

Site Status: RECRUITING

Kupat Cholim Clalit

Ramla, , Israel

Site Status: RECRUITING

Assaf Harofeh

Ẕerifin, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Mati Berkovitch, MD

Role: CONTACT

mberkovitch@asaf.health.gov.il

972 8 9779152

Eran Kozer, MD

Role: CONTACT

erank@asaf.health.gov.il

972 8 9778131

Facility Contacts

Al Garushi

Role: primary

Berkovitch

Role: primary

97289779152

Other Identifiers

20060504(142/06)

Identifier Type: -

Identifier Source: secondary_id

142/06

Identifier Type: -

Identifier Source: org_study_id