The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00156819
- Lead Sponsor
- JHSPH Center for Clinical Trials
- 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. 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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
- current or past smoking (greater than 20 pack-years)
- chronic or current oral steroid therapy
- pregnancy, lack of effective contraception (when appropriate), lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluticasone plus salmeterol Fluticasone plus salmeterol Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. Fluticasone Fluticasone plus salmeterol Participants continued fluticasone (100 microgram twice daily) treatment. Montelukast Fluticasone plus salmeterol Participants were changed to Montelukast (5 or 10 mg each night). Fluticasone fluticasone Participants continued fluticasone (100 microgram twice daily) treatment. Montelukast montelukast Participants were changed to Montelukast (5 or 10 mg each night). Fluticasone montelukast Participants continued fluticasone (100 microgram twice daily) treatment. Montelukast fluticasone Participants were changed to Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol montelukast Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. Fluticasone plus salmeterol fluticasone Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
- Primary Outcome Measures
Name Time Method Treatment Failure 16 weeks The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Washington University
🇺🇸St. Louis, Missouri, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University of Miami (and University of South Florida in Tampa)
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
National Jewish Hospital
🇺🇸Denver, Colorado, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Nemour's Childrens Center
🇺🇸Jacksonville, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
🇺🇸Chicago, Illinois, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, 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
Ohio State University
🇺🇸Columbus, Ohio, United States
Thomas Jefferson Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Northern New England Consortium (Univ. of Vermont and other locations)
🇺🇸Burlington, Vermont, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Missouri at Kansas City
🇺🇸Kansas City, Missouri, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States