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

NCT00127166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-05-10

Study results available
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Summary

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.

Conditions

  • Exercise Induced Asthma

Interventions

DRUG

Montelukast sodium

Montelukast 5 mg chewable tablet once daily

DRUG

Salmeterol xinafoate

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

DRUG

Fluticasone propionate

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

DRUG

Montelukast matching placebo

Matching placebo to montelukast oral tablet administered once daily.

DRUG

Salmeterol matching placebo

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-11-30
Completion
2008-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127166 on ClinicalTrials.gov