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NCT00148408 Clinical Trial

Trial of Asthma Patient Education (TAPE)

Asthma Clinical Trial

Official title:
Trial of Asthma Patient Education (TAPE)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00148408
Other study ID # ALAACRC-04
Secondary ID
Status Completed
Phase Phase 4
First received September 6, 2005
Last updated April 28, 2010
Start date December 2003
Est. completion date December 2005

Study information
Verified date September 2006
Source American Lung Association Asthma Clinical Research Centers
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 600
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast

Behavioral:
• Education

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Northern New England Consortium (Univ. of Vermont and other locations) Burlington Vermont
United States Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) Chicago Illinois
United States Ohio State University Columbus Ohio
United States National Jewish Hospital Denver Colorado
United States Duke University School of Medicine Durham North Carolina
United States Baylor College of Medicine Houston Texas
United States Indiana University Indianapolis Indiana
United States Nemour's Childrens Center Jacksonville Florida
United States University of Missouri at Kansas City Kansas City Missouri
United States University of Miami (and University of South Florida in Tampa) Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States Long Island Jewish Hospital (and North Shore Hospital) New Hyde Park New York
United States Louisiana State University New Orleans Louisiana
United States New York Consortium (New York Univ. and Columbia Univ.) New York New York
United States Thomas Jefferson Hospital Philadelphia Pennsylvania
United States University of California at San Diego San Diego California
United States Washington University St. Louis Missouri
United States New York Medical College Valhalla New York

Sponsors (2)
Lead Sponsor Collaborator
American Lung Association Asthma Clinical Research Centers National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Morning peak expiratory flow
Secondary Spirometry
Secondary Asthma diaries
Secondary Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life)
Secondary Generic health quality of life (SF-36)
Secondary Shortness of Breath Questionnaire
Secondary Adherence monitoring
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