Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Exercise Induced Asthma

Intervention / Treatment
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* Drug: Montelukast sodium
* Drug: Salmeterol xinafoate
* Drug: Fluticasone propionate
* Drug: Montelukast matching placebo
* Drug: Salmeterol matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-14 year old children with a history of asthma for at least 12 months must demonstrate airway constriction brought on by exercise Exclusion Criteria: is taking any medications that are not allowed in the study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast/Salmeterol<br>Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. | Drug: Montelukast sodium<br>* Montelukast 5 mg chewable tablet once daily<br>Drug: Salmeterol xinafoate<br>* Salmeterol 50 mcg dry powder per actuation inhaled twice daily<br>Drug: Fluticasone propionate<br>* Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily<br>Drug: Montelukast matching placebo<br>* Matching placebo to montelukast oral tablet administered once daily.<br>Drug: Salmeterol matching placebo<br>* Matching placebo to salmeterol dry powder for inhalation administered twice daily<br>|
| Experimental: Salmeterol/Montelukast<br>Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. | Drug: Montelukast sodium<br>* Montelukast 5 mg chewable tablet once daily<br>Drug: Salmeterol xinafoate<br>* Salmeterol 50 mcg dry powder per actuation inhaled twice daily<br>Drug: Fluticasone propionate<br>* Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily<br>Drug: Montelukast matching placebo<br>* Matching placebo to montelukast oral tablet administered once daily.<br>Drug: Salmeterol matching placebo<br>* Matching placebo to salmeterol dry powder for inhalation administered twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Post-exercise Percent (%) Fall in FEV1 | The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) | 
| Maximum FEV1 % Predicted Following First Beta-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) | 
| Time to Recovery to Within 5% of Baseline FEV1 | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) | 
| Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |