A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 62
- Primary Endpoint
- 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)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Montelukast - Placebo
Intervention: Comparator: Placebo (Drug)
2
Placebo - Montelukast
Intervention: Comparator: Placebo (Drug)
2
Placebo - Montelukast
Intervention: Comparator: Montelukast (Drug)
1
Montelukast - Placebo
Intervention: Comparator: Montelukast (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Secondary Outcomes
- Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose(0-90 minutes after the exercise challenge performed at 24 hours postdose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose)
- Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose)
- 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(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose)
- Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose(0-90 minutes after the exercise challenge performed at 2 hours postdose)
- Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose(0-90 minutes after the exercise challenge performed at 12 hours postdose)
- 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(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose)
- 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(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose(Exercise challenge at 2 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose(Exercise challenge at 12 hours postdose)
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose(Exercise challenge at 24 hours postdose)