CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Montelukast 4–5 mg orally once daily (dose by age: 4 mg granules for 12 months–2 years; 5 mg tablets for 2–3 years)AI-extracted
Key inclusion· 1
  • ✓Physician-diagnosed wheezing illness
Key exclusion· 3
  • ✕Asthma diagnosis
  • ✕Prematurity
  • ✕Known intolerance to montelukast

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00115297
NCT00115297Phase 3Completed
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Effects of Montelukast on Early Life Wheezing

University of Massachusetts, Worcester·interventional·Posted Jun 22, 2005·Updated Mar 14, 2017

In Brief

A Phase 3 clinical trial evaluating Montelukast and Placebo for Lung Diseases and Asthma. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Asthma
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 22, 2005
Enrollment StartSep 1, 2004
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 21.0 years ago

Interventions

Montelukastdrug

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.

Placebodrug

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.