Phase 3
N=51
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
Asthma, Exercise-Induced
Bottom Line
View on ClinicalTrials.gov: NCT00092131 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) — 22.33; 10.80 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: Montelukast (Drug); Comparator: Placebo (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Nov 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) |
22.33; 10.80 | — |
| SECONDARY Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose |
7; 1; 42; 48 | — |
| SECONDARY Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose |
5; 1; 43; 47 | — |
| SECONDARY Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose |
3; 1; 43; 45 | — |
| SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) |
16.12; 8.35 | — |
| SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) |
16.86; 8.33 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose |
702.13; 182.46 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose |
389.55; 152.27 | — |
| SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose |
409.50; 120.06 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose |
37.67; 10.82 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose |
24.50; 7.97 | — |
| SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose |
23.14; 5.74 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants with mild-to-moderate asthma
Exclusion Criteria
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Data sourced from ClinicalTrials.gov (NCT00092131). 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.