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Asthma |
Bronchial Asthma |
Clinical Trial: Trial of Asthma Patient Education (TAPE)
This study is currently recruiting patients.
Verified by American Lung Association Asthma Clinical Research Centers September 2005
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.
| Condition | Intervention | Phase |
|---|---|---|
| Asthma | Drug: Montelukast Behavior: Education | Phase IV |
MedlinePlus related topics: Asthma
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Morning peak expiratory flow
Secondary Outcomes: - 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
Expected Total Enrollment: 600
Secondary Outcomes: - 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
Expected Total Enrollment: 600
Study start: December 2003; Expected completion: December 2006
Last follow-up: December 2005; Data entry closure: March 2006
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?
Eligibility
Ages Eligible for Study: 15 Years and above, Genders Eligible for Study: Both
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), lacatation
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00148408
Ellen Brown 410-955-8175 ala-acrc@jhsph.edu
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States; Recruiting
Sue Erwin 205-934-5573
Lynn Gerald, PhD, Principal Investigator
Lynn Gerald, PhD, Principal Investigator
California
University of California at San Diego, San Diego, California, 92103, United States; Recruiting
Jane Vitin 619-294-6238
Stephen Wasserman, Principal Investigator
Stephen Wasserman, Principal Investigator
Colorado
National Jewish Hospital, Denver, Colorado, 80206, United States; Recruiting
Lisa Lopez 303-398-1233
Sally Wenzel, MD, Principal Investigator
Sally Wenzel, MD, Principal Investigator
Florida
Nemour''''s Childrens Center, Jacksonville, Florida, 32207, United States; Recruiting
Amber Santos 904-858-3985
John Lima, PharmD, Principal Investigator
John Lima, PharmD, Principal Investigator
University of Miami (and University of South Florida in Tampa), Miami, Florida, 33136, United States; Recruiting
Eliana Mendes 305-243-2568
Adam Wanner, MD, Principal Investigator
Adam Wanner, MD, Principal Investigator
Georgia
Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Rachna Patel 404-712-1773
W. Gerald Teague, MD, Principal Investigator
W. Gerald Teague, MD, Principal Investigator
Illinois
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois), Chicago, Illinois, 60611, United States; Recruiting
Jenny Hixon 312-926-0975
Lewis J Smith, MD, Principal Investigator
Lewis J Smith, MD, Principal Investigator
Indiana
Indiana University, Indianapolis, Indiana, 46202, United States; Recruiting
Paula Puntenney 317-274-1441
Michael Busk, MD, Principal Investigator
Michael Busk, MD, Principal Investigator
Louisiana
Louisiana State University, New Orleans, Louisiana, 70112, United States; Recruiting
Grenes Meyaski II 504-412-1676
Warren Summer, MD, Principal Investigator
Warren Summer, MD, Principal Investigator
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
Athena Decker 612-624-5456
Malcolm Blumenthal, MD, Principal Investigator
Malcolm Blumenthal, MD, Principal Investigator
Missouri
Washington University, St. Louis, Missouri, 63110, United States; Recruiting
Mary Ellen Scheipeter 314-362-8892
Mario Castro, MD, MPH, Principal Investigator
Mario Castro, MD, MPH, Principal Investigator
University of Missouri at Kansas City, Kansas City, Missouri, 64108, United States; Recruiting
Patti Haney 816-404-5503
Gary Salzman, MD, Principal Investigator
Gary Salzman, MD, Principal Investigator
New York
Long Island Jewish Hospital (and North Shore Hospital), New Hyde Park, New York, 11040, United States; Recruiting
Ramona Ramdeo 516-465-5461
Jill Karpel, MD, Principal Investigator
Jill Karpel, MD, Principal Investigator
New York Consortium (New York Univ. and Columbia Univ.), New York, New York, 10016, United States; Recruiting
Jeanine Futterman 212-263-0254
Joan Reibman, MD, Principal Investigator
Joan Reibman, MD, Principal Investigator
New York Medical College, Valhalla, New York, 10595, United States; Recruiting
Madelint Heydendael 914-493-7585
Allen Dozor, MD, Principal Investigator
Allen Dozor, MD, Principal Investigator
North Carolina
Duke University School of Medicine, Durham, North Carolina, 27710, United States; Recruiting
Ginny Dudek 919-684-0191
Larry Williams, MD, Principal Investigator
Larry Williams, MD, Principal Investigator
Ohio
Ohio State University, Columbus, Ohio, 43210, United States; Recruiting
Janice Drake 614-292-2107
John Mastronarde, MD, Principal Investigator
John Mastronarde, MD, Principal Investigator
Pennsylvania
Thomas Jefferson Hospital, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Michelle Hayes 215-955-7616
Frank Leone, MD, Principal Investigator
Frank Leone, MD, Principal Investigator
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Luz Giraldo 713-798-2682
Nick Hanania, MD, Principal Investigator
Nick Hanania, MD, Principal Investigator
Vermont
Northern New England Consortium (Univ. of Vermont and other locations), Burlington, Vermont, 05405, United States; Recruiting
Stephanie Burns 802-847-2103
Charles Irvin, PhD, Principal Investigator
Charles Irvin, PhD, Principal Investigator
Study chairs or principal investigators
Nicholas Anthonisen, MD, Study Chair, University of Winnipeg
More Information
Study ID Numbers: ALAACRC-04
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00148408
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00148408
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
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