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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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