The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)
Information source: American Lung Association Asthma Clinical Research Centers
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone (Drug); montelukast (Drug); fluticasone/salmeterol combination (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: American Lung Association Asthma Clinical Research Centers Official(s) and/or principal investigator(s):
Nicholas Anthonisen, MD, Study Chair, Affiliation: University of Winnipeg
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.
Clinical Details
Official title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Asthma treatment failure
Secondary outcome: Pulmonary functionSymptoms Medication use Patient measures (questionnaires) Markers of inflammation
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 controller therapy without loss of asthma control. Patients demonstrating
good control on twice-daily low-dose ICS will be randomized to one of three treatment groups:
once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or
once-daily combination therapy (fluticasone-salmeterol).
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- physician-diagnosed asthma
- age 6 or older
- pre-bronchodilator 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 Criteria:
- current or past smoking (greater than 20 pack-years)
- chronic or current oral steroid therapy
- pregnancy, lack of effective contraception (when appropriate), lactation
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
National Jewish Hospital, Denver, Colorado 80206, United States
Nemour's Childrens Center, Jacksonville, Florida 32207, United States
University of Miami (and University of South Florida in Tampa), Miami, Florida 33136, United States
Emory University, Atlanta, Georgia 30322, United States
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois), Chicago, Illinois 60611, United States
Indiana University, Indianapolis, Indiana 46202, United States
Louisiana State University, New Orleans, Louisiana 70112, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
University of Missouri at Kansas City, Kansas City, Missouri 64108, United States
Washington University, St. Louis, Missouri 63110, United States
Long Island Jewish Hospital (and North Shore Hospital), New Hyde Park, New York 11040, United States
New York Consortium (New York Univ. and Columbia Univ.), New York, New York 10016, United States
New York Medical College, Valhalla, New York 10595, United States
Duke University School of Medicine, Durham, North Carolina 27710, United States
Ohio State University, Columbus, Ohio 43210, United States
Thomas Jefferson Hospital, Philadelphia, Pennsylvania 19107, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Northern New England Consortium (Univ. of Vermont and other locations), Burlington, Vermont 05405, United States
Additional Information
American Lung Association Asthma Clinical Research Centers
Starting date: June 2003
Ending date: July 2005
Last updated: September 8, 2005
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