The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00156819

Run by

JHSPH Center for Clinical Trials

People needed

500

Starts

2003-06-01

Expected to finish

2006-08-01

Last updated by the study team

2015-12-09

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• National Jewish Hospital — Denver, Colorado, United States
• Nemour's Childrens Center — Jacksonville, Florida, United States
• University of Miami (and University of South Florida in Tampa) — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Louisiana State University — New Orleans, Louisiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Missouri at Kansas City — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Long Island Jewish Hospital (and North Shore Hospital) — New Hyde Park, New York, United States
• New York Consortium (New York Univ. and Columbia Univ.) — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Northern New England Consortium (Univ. of Vermont and other locations) — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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