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Montelukast for Early Life Wheezing

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Craig Lilly, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00115297
First received: June 21, 2005
Last updated: February 3, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Montelukast on Early Life Wheezing

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) [ Time Frame: First 56 days of study ]

Secondary Outcome Measures:
  • Wheezing at Day 7 [ Time Frame: Study day 7 ]
  • The Number of Participants Requiring Rescue Beta Agonist Use [ Time Frame: Measured during the daytime ]

Enrollment: 62
Study Start Date: September 2004
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Placebo Comparator: 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.
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.

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:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
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
Worcester, Massachusetts, United States, 01650
Sponsors and Collaborators
University of Massachusetts, Worcester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Craig M. Lilly, MD University of Massachusetts/UMass Memorial
  More Information

Responsible Party: Craig Lilly, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00115297     History of Changes
Other Study ID Numbers: 192
R01HL080073 ( U.S. NIH Grant/Contract )
Study First Received: June 21, 2005
Results First Received: December 12, 2016
Last Updated: February 3, 2017

Additional relevant MeSH terms:
Lung Diseases
Respiratory Sounds
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017