Montelukast for Early Life Wheezing
Effects of Montelukast on Early Life Wheezing
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
February 6, 2017
CompletedMarch 14, 2017
February 1, 2017
12.1 years
June 21, 2005
December 12, 2016
February 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)
First 56 days of study
Secondary Outcomes (2)
Wheezing at Day 7
Study day 7
The Number of Participants Requiring Rescue Beta Agonist Use
Measured during the daytime
Study Arms (2)
Montelukast
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Physician-diagnosed wheezing illness
You may not qualify if:
- Asthma
- Prematurity
- Known intolerance to montelukast
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts/UMass Memorial
Worcester, Massachusetts, 01650, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig M. Lilly, MD
- Organization
- UMass
Study Officials
- STUDY CHAIR
Craig M. Lilly, MD
University of Massachusetts/UMass Memorial
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
September 1, 2004
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 14, 2017
Results First Posted
February 6, 2017
Record last verified: 2017-02