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| Sponsors and Collaborators: |
American Lung Association Asthma Clinical Research Centers GlaxoSmithKline |
|---|---|
| Information provided by: | American Lung Association Asthma Clinical Research Centers |
| ClinicalTrials.gov Identifier: | NCT00156819 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: fluticasone Drug: montelukast Drug: fluticasone/salmeterol combination |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial) |
| Estimated Enrollment: | 495 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | July 2005 |
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| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Colorado | |
| National Jewish Hospital | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| Nemour's Childrens Center | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami (and University of South Florida in Tampa) | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Louisiana State University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| University of Missouri at Kansas City | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Long Island Jewish Hospital (and North Shore Hospital) | |
| New Hyde Park, New York, United States, 11040 | |
| New York Consortium (New York Univ. and Columbia Univ.) | |
| New York, New York, United States, 10016 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Duke University School of Medicine | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Thomas Jefferson Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Northern New England Consortium (Univ. of Vermont and other locations) | |
| Burlington, Vermont, United States, 05405 | |
| Study Chair: | Nicholas Anthonisen, MD | University of Winnipeg |
More Information
| Study ID Numbers: | ALAACRC-03 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| ClinicalTrials.gov Identifier: | NCT00156819 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Asthma Control |
|
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Hormones |
Adrenergic Agonists Leukotriene Antagonists Montelukast Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic Agonists Leukotriene Antagonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses |
Fluticasone Dermatologic Agents Salmeterol Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Montelukast Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents |
