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

NCT ID: NCT00127166

Last Updated: 2024-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-11-30

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.

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Detailed Description

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Conditions

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Exercise Induced Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Montelukast/Salmeterol

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.

Group Type EXPERIMENTAL

Montelukast sodium

Intervention Type DRUG

Montelukast 5 mg chewable tablet once daily

Salmeterol xinafoate

Intervention Type DRUG

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Fluticasone propionate

Intervention Type DRUG

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

Montelukast matching placebo

Intervention Type DRUG

Matching placebo to montelukast oral tablet administered once daily.

Salmeterol matching placebo

Intervention Type DRUG

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Salmeterol/Montelukast

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.

Group Type EXPERIMENTAL

Montelukast sodium

Intervention Type DRUG

Montelukast 5 mg chewable tablet once daily

Salmeterol xinafoate

Intervention Type DRUG

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Fluticasone propionate

Intervention Type DRUG

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

Montelukast matching placebo

Intervention Type DRUG

Matching placebo to montelukast oral tablet administered once daily.

Salmeterol matching placebo

Intervention Type DRUG

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Interventions

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Montelukast sodium

Montelukast 5 mg chewable tablet once daily

Intervention Type DRUG

Salmeterol xinafoate

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Intervention Type DRUG

Fluticasone propionate

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

Intervention Type DRUG

Montelukast matching placebo

Matching placebo to montelukast oral tablet administered once daily.

Intervention Type DRUG

Salmeterol matching placebo

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Intervention Type DRUG

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.

Reference Type DERIVED
PMID: 20568384 (View on PubMed)

Other Identifiers

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2004_006

Identifier Type: OTHER

Identifier Source: secondary_id

0476-911

Identifier Type: -

Identifier Source: org_study_id

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