Trial of Asthma Patient Education (TAPE)
- Conditions
- Asthma
- Registration Number
- NCT00148408
- Lead Sponsor
- American Lung Association Asthma Clinical Research Centers
- 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Morning peak expiratory flow
- Secondary Outcome Measures
Name Time Method Spirometry Asthma diaries Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life) Generic health quality of life (SF-36) Shortness of Breath Questionnaire Adherence monitoring
Trial Locations
- Locations (20)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Miami (and University of South Florida in Tampa)
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Northern New England Consortium (Univ. of Vermont and other locations)
🇺🇸Burlington, Vermont, United States
University of California at San Diego
🇺🇸San Diego, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Washington University
🇺🇸St. Louis, Missouri, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
National Jewish Hospital
🇺🇸Denver, Colorado, United States
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
🇺🇸Chicago, Illinois, United States
Nemour's Childrens Center
🇺🇸Jacksonville, Florida, United States
New York Consortium (New York Univ. and Columbia Univ.)
🇺🇸New York, New York, United States
University of Missouri at Kansas City
🇺🇸Kansas City, Missouri, United States
Long Island Jewish Hospital (and North Shore Hospital)
🇺🇸New Hyde Park, New York, United States
Thomas Jefferson Hospital
🇺🇸Philadelphia, Pennsylvania, United States