CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
Comparator: Montelukast +1 moredrug
Likely dose
Montelukast 10 mg orally as a single dose before exercise challengeAI-extracted
Key inclusion· 1
  • ✓Mild-to-moderate asthma
Key exclusion· 2
  • ✕Medical history of a lung disorder other than asthma
  • ✕Recent upper respiratory tract infection

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

Search/NCT00092131
NCT00092131Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm

Organon and Co·interventional·Posted Sep 24, 2004·Updated Feb 2, 2022

In Brief

A Phase 3 clinical trial evaluating Comparator: Montelukast and Comparator: Placebo for Asthma, Exercise-Induced. Completed, enrolled 51 participants.

Detailed Summary

The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who have a history of worsening asthma after exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Exercise-Induced
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2004
Enrollment StartJun 1, 2003
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 21.8 years ago

Interventions

Comparator: Montelukastdrug

Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge

Comparator: Placebodrug

Placebo tablet administered orally as a single witnessed dose before exercise challenge