Status:

COMPLETED

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Lead Sponsor:

JHSPH Center for Clinical Trials

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Asthma

Eligibility:

All Genders

6+ years

Phase:

PHASE4

Brief 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. T...

Detailed Description

This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of contr...

Eligibility Criteria

Inclusion

  • physician-diagnosed asthma
  • age 6 or older
  • pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
  • beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
  • Juniper Asthma Control Score of 1.5 or greater if not on daily controller
  • good current health

Exclusion

  • current or past smoking (greater than 20 pack-years)
  • chronic or current oral steroid therapy
  • pregnancy, lack of effective contraception (when appropriate), lactation

Key Trial Info

Start Date :

June 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2006

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT00156819

Start Date

June 1 2003

End Date

August 1 2006

Last Update

December 9 2015

Active Locations (19)

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Page 1 of 5 (19 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

National Jewish Hospital

Denver, Colorado, United States, 80206

3

Nemour's Childrens Center

Jacksonville, Florida, United States, 32207

4

University of Miami (and University of South Florida in Tampa)

Miami, Florida, United States, 33136