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The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

NCT00156819 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-12-09

Study results available
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Summary

This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Conditions

Interventions

DRUG

fluticasone

fluticasone (100 microgram twice daily) treatment

DRUG

montelukast

Montelukast (5 or 10 mg each night).

DRUG

Fluticasone plus salmeterol

fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Nicholas Anthonisen, MD · University of Winnipeg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00156819 on ClinicalTrials.gov