Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-Blind, Placebo-Controlled Study
Information source: Assaf-Harofeh Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Upper Respiratory Tract Infection
Intervention: Muntelukast (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assaf-Harofeh Medical Center Official(s) and/or principal investigator(s):
Mati Berkovitch, MD, Principal Investigator, Affiliation: Assaf-Harofeh Medical Center
Eran Kozer, MD, Principal Investigator, Affiliation: Assaf-Harofeh Medical Center
Overall contact:
Mati Berkovitch, MD, Phone: 972 8 9779152, Email: mberkovitch@asaf.health.gov.il
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.
Clinical Details
Official title: Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Study design: Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The number and duration of URI episodes
Secondary outcome: 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.
Eligibility
Minimum age: 1 Year.
Maximum age: 5 Years.
Gender(s): Both.
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.
Locations and Contacts
Mati Berkovitch, MD, Phone: 972 8 9779152, Email: mberkovitch@asaf.health.gov.il
Assaf Harofeh, Zerifin 70300, Israel; Recruiting
Berkovitch, Phone: 97289779152
Mati Berkovitch, MD, Principal Investigator
Kupat Cholim Clalit, Ramla, Israel; Recruiting
Zachi Lotem, Principal Investigator
Kupat Cholim Clalit, Lod, Israel; Recruiting
Al Garushi
Al Garushi, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: June 2010
Last updated: April 27, 2009
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