Phase 3
N=47
Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Asthma, Exercise-Induced
Bottom Line
View on ClinicalTrials.gov: NCT00245570 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
May 2010
Primary outcome: Primary: Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) — 13.15; 10.46; 21.86 Percent Change from Baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: Montelukast (Drug); Comparator: Salmeterol (Drug); Comparator: Placebo (montelukast) (Drug); Comparator: Placebo (salmeterol) (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) |
13.15; 10.46; 21.86 | — |
| SECONDARY Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose |
3; 4; 9; 44; 42; 38 | — |
| SECONDARY Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose |
0; 0; 4; 40; 39; 33 | — |
| SECONDARY Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose |
3; 6; 6; 43; 40; 40 | — |
| SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB |
11.60; 11.01; 16.65 | — |
| SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB |
10.09; 16.22; 13.64 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose |
254.60; 293.05; 710.43 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose |
191.01; 276.26; 511.28 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose |
231.09; 554.93; 395.96 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose |
16.63; 17.58; 42.70 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose |
10.70; 13.82; 32.34 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose |
11.04; 29.75; 23.31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Physician-diagnosed exercise-induced bronchospasm
Exclusion Criteria
- Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
Data sourced from ClinicalTrials.gov (NCT00245570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.