Montelukast for Early Life Wheezing

NCT ID: NCT00115297

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2016-10-31

Brief 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.

Detailed 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.

Conditions

Lung Diseases; Asthma

Study Design

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

Study Groups

Montelukast

Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.

Placebo

Participants who are 2 to 3 years old received 5-mg montelukast placebo tablets and participants who are 12 months to 2 years old received 4-mg montelukast placebo granules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.

Interventions

Montelukast

Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.

Intervention Type: DRUG

Placebo

Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Physician-diagnosed wheezing illness

Exclusion Criteria

• Asthma
• Prematurity
• Known intolerance to montelukast

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Craig Lilly

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig M. Lilly, MD

Role: STUDY_CHAIR

University of Massachusetts/UMass Memorial

Locations

University of Massachusetts/UMass Memorial

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

R01HL080073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

192

Identifier Type: -

Identifier Source: org_study_id