CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
Comparator: Montelukast +3 moredrug
Likely dose
Montelukast 10 mg orally (single dose) or salmeterol 50 mcg by inhalation (single dose)AI-extracted
Key inclusion· 1
  • Physician-diagnosed exercise-induced bronchospasm
Key exclusion· 1
  • Any significant health condition other than asthma that is not in good, stable health status

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

Search/NCT00245570
NCT00245570Phase 3Completed

A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction

Organon and Co·interventional·Posted Oct 28, 2005·Updated Feb 2, 2022

In Brief

A Phase 3 clinical trial evaluating Comparator: Montelukast, Comparator: Salmeterol, and 2 other interventions for Asthma, Exercise-Induced. Completed, enrolled 47 participants.

Detailed Summary

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
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 2005
Enrollment StartDec 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.7 years ago

Interventions

Comparator: Montelukastdrug

1 dose montelukast 10 mg tablet given orally in one of three treatment periods

Comparator: Salmeteroldrug

1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods

Comparator: Placebo (montelukast)drug

1 dose matching-image placebo to montelukast tablet in two of three treatment periods

Comparator: Placebo (salmeterol)drug

1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods