CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Comparator: Montelukast +1 moredrug
Likely dose
Montelukast 10 mg tablet orally as a single dose before exercise challengeAI-extracted
Key inclusion· 1
  • Diagnosis of mild-to-moderate asthma
Key exclusion· 3
  • Medical history of a lung disorder other than asthma
  • Recent upper respiratory tract infection
  • Not in good, stable health (other than asthma)

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

Search/NCT00090142
NCT00090142Phase 3Completed

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 Aug 26, 2004·Updated Feb 2, 2022

In Brief

A Phase 3 clinical trial evaluating Comparator: Montelukast and Comparator: Placebo for Asthma, Exercise-Induced. Completed, enrolled 62 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 patients who have a history of worsening asthma after exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2004
Enrollment StartMay 1, 2004
Primary CompletionOct 1, 2004
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