CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 364 enrolled
Drug / intervention
Comparator: montelukast sodium +1 moredrug
Likely dose
Comparator: montelukast sodium 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00534976
NCT00534976Phase 4Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years

Organon and Co·interventional·Posted Sep 26, 2007·Updated May 13, 2024

In Brief

A Phase 4 clinical trial evaluating Comparator: montelukast sodium and Comparator: Comparator: placebo (unspecified) for Exercise-induced Bronchoconstriction (EIB). Completed, enrolled 364 participants.

Detailed Summary

This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExercise-induced Bronchoconstriction (EIB)
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2007
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.8 years ago

Interventions

Comparator: montelukast sodiumdrug

Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily

Comparator: Comparator: placebo (unspecified)drug

Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily