Phase 3 N=62 Randomized Double-blind Prevention

Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)

Asthma, Exercise-Induced

Bottom Line

View on ClinicalTrials.gov: NCT00090142 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2010

Primary outcome: Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) — 17.50; 11.70 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: Oct 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)	17.50; 11.70	—
SECONDARY Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose	7; 2; 47; 52	—
SECONDARY Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose	4; 2; 48; 50	—
SECONDARY Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose	2; 2; 50; 50	—
SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB	11.73; 9.87	—
SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB	10.69; 7.95	—
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	582.6; 284.7	—
SECONDARY Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose	314.0; 241.7	—
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	269.6; 223.1	—
SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose	34.23; 15.87	—
SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose	23.40; 9.42	—
SECONDARY Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose	13.81; 9.47	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with mild-to-moderate asthma

Exclusion Criteria

Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090142). 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.