Montelukast for Early Life Wheezing

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Massachusetts, Worcester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig Lilly, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00115297
First received: June 21, 2005
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lung Diseases
Asthma
Drug: Montelukast
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Montelukast on Early Life Wheezing

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Number of wheezing-free days of infant (observed by primary caregiver) [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of wheezing episodes during treatment period [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Rate of recurrent wheezing during follow-up period [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2004
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5-mg montelukast tablets
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 Comparator: 2
Placebo (montelukast tablets)
Drug: 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.
Experimental: 3
4-mg montelukast granules
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 Comparator: 4
Placebo (montelukast granules)
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician-diagnosed wheezing illness

Exclusion Criteria:

  • Asthma
  • Prematurity
  • Known intolerance to montelukast
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115297

Locations
United States, Massachusetts
University of Massachusetts/UMass Memorial Recruiting
Worcester, Massachusetts, United States, 01650
Contact: Dr. Can Omer Kalayci       okalayci@ato.org.tr   
Principal Investigator: Craig M. Lilly, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Study Chair: Craig M. Lilly, MD University of Massachusetts/UMass Memorial
  More Information

No publications provided

Responsible Party: Craig Lilly, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00115297     History of Changes
Other Study ID Numbers: 192, R01HL080073, R01 HL80073
Study First Received: June 21, 2005
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014