NCT00551382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 17, 2010

Status Verified

March 1, 2010

Enrollment Period

2.1 years

First QC Date

October 30, 2007

Last Update Submit

March 16, 2010

Conditions

Upper Respiratory Tract Infection

Keywords

MontelukastUpper respiratory tract infectionleukotrieneChildren

Outcome Measures

Primary Outcomes (1)

  • The number and duration of URI episodes

    3 month

Secondary Outcomes (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.

    3 month

Study Arms (2)

A

EXPERIMENTAL
Drug: Muntelukast

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MuntelukastDRUG

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

Also known as: Singulair
A
PlaceboDRUG

Look alike tablets or granules 1 per day for 12 weeks

B

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 1 to 5 years old without significant health problem.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kupat Cholim Clalit

Lod, Israel

RECRUITING

Kupat Cholim Clalit

Ramla, Israel

RECRUITING

Assaf Harofeh

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

montelukast

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Mati Berkovitch, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

  • Eran Kozer, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mati Berkovitch, MD

CONTACT

972 8 9779152mberkovitch@asaf.health.gov.il

Eran Kozer, MD

CONTACT

972 8 9778131erank@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

March 17, 2010

Record last verified: 2010-03

Locations

IL(3)