The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)
Overview[ - collapse ][ - ]
| 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 | Asthma |
| Intervention | Drug: fluticasone Drug: montelukast Drug: fluticasone/salmeterol combination |
| Phase | Phase 4 |
| Sponsor | American Lung Association Asthma Clinical Research Centers |
| Responsible Party | American Lung Association Asthma Clinical Research Centers |
| ClinicalTrials.gov Identifier | NCT00156819 |
| First Received | September 8, 2005 |
| Last Updated | August 26, 2011 |
| Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 8, 2005 |
|---|---|
| Last Updated Date | August 26, 2011 |
| Start Date | June 2003 |
| Estimated Primary Completion Date | July 2005 |
| Current Primary Outcome Measures | Asthma treatment failure |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial) |
|---|---|
| Official Title | The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial) |
| 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). |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: fluticasone Drug: montelukast Drug: fluticasone/salmeterol combination |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 495 |
| Estimated Completion Date | July 2005 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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 |
| Gender | Both |
| Ages | 6 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00156819 |
|---|---|
| Other Study ID Numbers | ALAACRC-03 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | American Lung Association Asthma Clinical Research Centers |
| Study Sponsor | American Lung Association Asthma Clinical Research Centers |
| Collaborators | GlaxoSmithKline |
| Investigators | Study Chair: Nicholas Anthonisen, MD University of Winnipeg |
| Verification Date | August 2011 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham | Birmingham, Alabama, United States, 35233 |
|---|---|
| National Jewish Hospital | Denver, Colorado, United States, 80206 |
| Nemour's Childrens Center | Jacksonville, Florida, United States, 32207 |
| University of Miami (and University of South Florida in Tampa) | Miami, Florida, United States, 33136 |
| Emory University | Atlanta, Georgia, United States, 30322 |
| Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) | Chicago, Illinois, United States, 60611 |
| Indiana University | Indianapolis, Indiana, United States, 46202 |
| Louisiana State University | New Orleans, Louisiana, United States, 70112 |
| University of Minnesota | Minneapolis, Minnesota, United States, 55455 |
| University of Missouri at Kansas City | Kansas City, Missouri, United States, 64108 |
| Washington University | St. Louis, Missouri, United States, 63110 |
| 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 |
| Duke University School of Medicine | Durham, North Carolina, United States, 27710 |
| Ohio State University | Columbus, Ohio, United States, 43210 |
| Thomas Jefferson Hospital | Philadelphia, Pennsylvania, United States, 19107 |
| Baylor College of Medicine | Houston, Texas, United States, 77030 |
| Northern New England Consortium (Univ. of Vermont and other locations) | Burlington, Vermont, United States, 05405 |