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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00115297
Other study ID # 192
Secondary ID R01HL080073
Status Active, not recruiting
Phase Phase 2/Phase 3
First received June 21, 2005
Last updated October 31, 2015
Start date September 2004
Est. completion date September 2020

Study information

Verified date October 2015
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who visit a physician for care of a wheezing illness. Only patients from the Ankara area of Hacettepe University Medical Center in Turkey will be included in this study.


Description:

BACKGROUND:

Asthma has a large impact on the children of our society. It is among the most common chronic diseases of childhood and is the leading cause of absenteeism from school. It is unknown as to why more children are having recurrent episodes of wheezing and why some children have asthma while others do not. There is increasing evidence that differences in innate immune responses among children can determine which child will have recurrent wheezing and asthma. While many studies have focused on the factors that initiate innate immune responses, there are relatively few studies of the downstream factors that cause abnormal airway responses. There is evidence that eicosanoid mediators are part of the innate immune response and can function as its effector arm for allergic responses. The ability of leukotrienes and prostaglandins to produce central features of the asthma phenotype is well described and there is emerging evidence that lipoxins facilitate restoration of allergic changes in the airways. This study will test the hypothesis that the balance of airway eicosanoid expression during early-life wheezing illness and the genetically determined capacity to respond will predict recurrent wheezing. Moreover, an intervention to restore a more normal tissue response to this imbalance will reduce symptoms of early-life wheezing and subsequent recurrent episodes.

DESIGN NARRATIVE:

This will be a prospective, double-blind, randomized, placebo-controlled, parallel-group study of the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who are under the care of a physician for a wheezing illness. Study treatment will be given for 56 days. Participants who are 2 to 3 years old will receive either 5-mg montelukast tablets or matching placebo. Participants who are 12 months to 2 years old will receive 4-mg montelukast granules or matching placebo. The primary outcome parameter of this study will be the number of days that the infant is observed to be free of wheezing by the primary caregiver. The secondary outcome parameters will be the number of wheezing episodes during the treatment period and the rate of recurrent wheezing during the follow-up period. The study, which is a consortium arrangement between the Brigham and Women's Hospital and the Hacettepe University Medical Center in Turkey, will recruit children only from the Ankara area of Hacettepe University Medical Center in Turkey.

This study will be one of three, which include: 1) measuring the airway eicosanoid profiles of pediatric "wheezing" patients 3 months to 3 years old; 2) determining if genetic variants in eicosanoid metabolic and response pathways are associated with recurrent wheezing; and 3) determining how intervention with montelukast (singulair) affects symptoms and the rate of recurrent wheezing.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 3 Years
Eligibility Inclusion Criteria:

- Physician-diagnosed wheezing illness

Exclusion Criteria:

- Asthma

- Prematurity

- Known intolerance to montelukast

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Montelukast
Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules.
Placebo
Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules.

Locations

Country Name City State
United States University of Massachusetts/UMass Memorial Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Worcester National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of wheezing-free days of infant (observed by primary caregiver) Measured throughout the study No
Secondary Number of wheezing episodes during treatment period Measured throughout the study No
Secondary Rate of recurrent wheezing during follow-up period Measured throughout the study No
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