Trials / Completed
CompletedNCT00127166
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Montelukast sodium | Montelukast 5 mg chewable tablet once daily |
| DRUG | Salmeterol xinafoate | Salmeterol 50 mcg dry powder per actuation inhaled twice daily |
| DRUG | Fluticasone propionate | Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily |
| DRUG | Montelukast matching placebo | Matching placebo to montelukast oral tablet administered once daily. |
| DRUG | Salmeterol matching placebo | Matching placebo to salmeterol dry powder for inhalation administered twice daily |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2005-08-05
- Last updated
- 2024-05-10
- Results posted
- 2009-12-03
Source: ClinicalTrials.gov record NCT00127166. Inclusion in this directory is not an endorsement.