Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-Blind, Placebo-Controlled Study - Full Text View

Sponsor:	Assaf-Harofeh Medical Center
Collaborator:	Merck
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00551382

Purpose

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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
A: Experimental	Drug: Muntelukast Tablets or granules; 4 mg once a day for 12 weeks
B: Placebo Comparator	Drug: Placebo Look alike tablets or granules 1 per day for 12 weeks

Eligibility

Ages Eligible for Study:	1 Year to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551382

Contacts

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

Locations

Israel
Assaf Harofeh	Recruiting
Zerifin, Israel, 70300
Contact: Berkovitch 97289779152
Principal Investigator: Mati Berkovitch, MD
Kupat Cholim Clalit	Recruiting
Ramla, Israel
Principal Investigator: Zachi Lotem
Kupat Cholim Clalit	Recruiting
Lod, Israel
Contact: Al Garushi
Principal Investigator: Al Garushi, MD

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Merck

Investigators

Principal Investigator:	Mati Berkovitch, MD	Assaf-Harofeh Medical Center
Principal Investigator:	Eran Kozer, MD	Assaf-Harofeh Medical Center

More Information

No publications provided

Responsible Party:	Assaf Harofeh Medical Center ( Berkovitch M )
Study ID Numbers:	142/06, 20060504(142/06)
Study First Received:	October 30, 2007
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00551382 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Montelukast
Upper respiratory tract infection
leukotriene
Children

Additional relevant MeSH terms:

Communicable Diseases
Respiratory System Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Infection

Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2010