Trial of Asthma Patient Education (TAPE)
1 other identifier
interventional
600
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Dec 2003
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 30, 2010
September 1, 2006
2 years
September 6, 2005
April 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morning peak expiratory flow
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California at San Diego
San Diego, California, 92103, United States
National Jewish Hospital
Denver, Colorado, 80206, United States
Nemour's Childrens Center
Jacksonville, Florida, 32207, United States
University of Miami (and University of South Florida in Tampa)
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Missouri at Kansas City
Kansas City, Missouri, 64108, United States
Washington University
St Louis, Missouri, 63110, United States
Long Island Jewish Hospital (and North Shore Hospital)
New Hyde Park, New York, 11040, United States
New York Consortium (New York Univ. and Columbia Univ.)
New York, New York, 10016, United States
New York Medical College
Valhalla, New York, 10595, United States
Duke University School of Medicine
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Northern New England Consortium (Univ. of Vermont and other locations)
Burlington, Vermont, 05405, United States
Related Publications (2)
Gerald JK, Carr TF, Wei CY, Holbrook JT, Gerald LB. Albuterol Overuse: A Marker of Psychological Distress? J Allergy Clin Immunol Pract. 2015 Nov-Dec;3(6):957-62. doi: 10.1016/j.jaip.2015.06.021. Epub 2015 Sep 1.
PMID: 26341049DERIVEDWise RA, Bartlett SJ, Brown ED, Castro M, Cohen R, Holbrook JT, Irvin CG, Rand CS, Sockrider MM, Sugar EA; American Lung Association Asthma Clinical Research Centers. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. J Allergy Clin Immunol. 2009 Sep;124(3):436-44, 444e1-8. doi: 10.1016/j.jaci.2009.05.041. Epub 2009 Jul 25.
PMID: 19632710DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicholas Anthonisen, MD
University of Winnipeg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
December 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 30, 2010
Record last verified: 2006-09