The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2003 |
| End Date: | August 2006 |
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.
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.
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).
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).
Inclusion Criteria:
- 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 Criteria:
- current or past smoking (greater than 20 pack-years)
- chronic or current oral steroid therapy
- pregnancy, lack of effective contraception (when appropriate), lactation
We found this trial at
19
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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New York Medical College The College was founded in 1860 by a group of New...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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