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Completed

NCT Number: NCT00127166

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

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.

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Key information

Conditions

Exercise Induced Asthma Asthma Asthma, Exercise-Induced Bronchial Diseases Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

Montelukast 5 mg chewable tablet once daily

Salmeterol xinafoate

Drug

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Fluticasone propionate

Drug

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

Montelukast matching placebo

Drug

Matching placebo to montelukast oral tablet administered once daily.

Salmeterol matching placebo

Drug

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Primary outcomes

  1. Maximum Post-exercise Percent (%) Fall in FEV1

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

    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.

Secondary outcomes

  1. Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))

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

    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.

  2. Maximum FEV1 % Predicted Following First Beta-agonist Use

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

    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.

  3. Time to Recovery to Within 5% of Baseline FEV1

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

    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. Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use

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

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 5, 2005
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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