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.
ConditionAsthma
InterventionDrug: Montelukast
Behavioral: Education
PhasePhase 4
SponsorAmerican Lung Association Asthma Clinical Research Centers
Responsible PartyAmerican Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov IdentifierNCT00148408
First ReceivedSeptember 6, 2005
Last UpdatedApril 28, 2010
Last verifiedSeptember 2006

Tracking Information[ + expand ][ + ]

First Received DateSeptember 6, 2005
Last Updated DateApril 28, 2010
Start DateDecember 2003
Estimated Primary Completion DateDecember 2005
Current Primary Outcome MeasuresMorning peak expiratory flow
Current Secondary Outcome Measures
  • 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

Descriptive Information[ + expand ][ + ]

Brief TitleTrial of Asthma Patient Education (TAPE)
Official TitleTrial 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind
ConditionAsthma
InterventionDrug: Montelukast
Behavioral: Education
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment600
Estimated Completion DateDecember 2005
Estimated Primary Completion DateDecember 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
GenderBoth
Ages15 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00148408
Other Study ID NumbersALAACRC-04
Has Data Monitoring CommitteeNot Provided
Information Provided ByAmerican Lung Association Asthma Clinical Research Centers
Study SponsorAmerican Lung Association Asthma Clinical Research Centers
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Investigators Study Chair: Nicholas Anthonisen, MD University of Winnipeg
Verification DateSeptember 2006

Locations[ + expand ][ + ]

University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
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