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Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

NCT00245570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-02-02

Study results available
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Summary

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.

Conditions

  • Asthma, Exercise-Induced

Interventions

DRUG

Comparator: Montelukast

1 dose montelukast 10 mg tablet given orally in one of three treatment periods

DRUG

Comparator: Salmeterol

1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods

DRUG

Comparator: Placebo (montelukast)

1 dose matching-image placebo to montelukast tablet in two of three treatment periods

DRUG

Comparator: Placebo (salmeterol)

1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-09-30
Completion
2006-09-30

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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 NCT00245570 on ClinicalTrials.gov