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

Organon and Co154 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Exercise Induced Asthma

Interventions

Montelukast sodiumDRUG

Montelukast 5 mg chewable tablet once daily

Salmeterol xinafoateDRUG

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Fluticasone propionateDRUG

Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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