Trial of Asthma Patient Education (TAPE)
Overview[ - collapse ][ - ]
Purpose | The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma. |
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Condition | Asthma |
Intervention | Drug: Montelukast Behavioral: Education |
Phase | Phase 4 |
Sponsor | American Lung Association Asthma Clinical Research Centers |
Responsible Party | American Lung Association Asthma Clinical Research Centers |
ClinicalTrials.gov Identifier | NCT00148408 |
First Received | September 6, 2005 |
Last Updated | April 28, 2010 |
Last verified | September 2006 |
Tracking Information[ + expand ][ + ]
First Received Date | September 6, 2005 |
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Last Updated Date | April 28, 2010 |
Start Date | December 2003 |
Estimated Primary Completion Date | December 2005 |
Current Primary Outcome Measures | Morning peak expiratory flow |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Trial of Asthma Patient Education (TAPE) |
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Official Title | Trial of Asthma Patient Education (TAPE) |
Brief Summary | The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma. |
Detailed Description | This is a study of the effects of education and drug presentation on efficacy of montelukast and placebo in asthma. This trial will answer the following questions: 1) Is there a true placebo response in asthma that is not due to non-specific factors? 2) Can the placebo effect in asthma be augmented by interventions that increase expectancy of benefit? 3) Can interventions that increase expectancy augment the effect of active treatment? 4) Are placebo effects additive or interactive with treatment effects? |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind |
Condition | Asthma |
Intervention | Drug: Montelukast Behavioral: Education |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 600 |
Estimated Completion Date | December 2005 |
Estimated Primary Completion Date | December 2005 |
Eligibility Criteria | Inclusion Criteria: - age 15 or older - physician diagnosed asthma - regular use of prescribed asthma medication over preceding year - post-bronchodilator FEV1 of at least 75% of predicted - inadequate asthma control over preceding two months Exclusion Criteria: - current or past smoking (greater than 10 pack-years) - serious asthma exacerbation within previous three months - regular use of oral corticosteroids - history of respiratory failure due to asthma - current use of montelukast or history of adverse reaction to montelukast - concomitant interfering medical condition - participation in another clinical trial - inability or unwillingness to perform study procedures - pregnancy, lack of effective contraception (when appropriate), lactation |
Gender | Both |
Ages | 15 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00148408 |
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Other Study ID Numbers | ALAACRC-04 |
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 | National Heart, Lung, and Blood Institute (NHLBI) |
Investigators | Study Chair: Nicholas Anthonisen, MD University of Winnipeg |
Verification Date | September 2006 |
Locations[ + expand ][ + ]
University of Alabama at Birmingham | Birmingham, Alabama, United States, 35233 |
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University of California at San Diego | San Diego, California, United States, 92103 |
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 |