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CompletedNCT00148408Updated Apr 30, 2010

Trial of Asthma Patient Education (TAPE)

A Phase 4 interventional study of Montelukast and Education in Asthma, sponsored by American Lung Association Asthma Clinical Research Centers. Completed at 20 sites in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2010-04-30.

Sponsored by American Lung Association Asthma Clinical Research Centers · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
15 Years and older
Sex
All
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Study 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.

Read the 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?

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Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Placebo
  • Education
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 600 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

American Lung Association Asthma Clinical Research Centers is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double
Enrollment
600 participants

Interventions

  • DrugMontelukast
  • BehavioralEducation
06

What researchers measure

Primary outcomes

  1. Morning peak expiratory flow

Secondary outcomes

  1. Spirometry

  2. Asthma diaries

  3. Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life)

  4. Generic health quality of life (SF-36)

  5. Shortness of Breath Questionnaire

  6. Adherence monitoring

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Study locations

20 sites
  • 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
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References and documents

Publications

  • 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. PubMed 26341049 ↗
  • Wise 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. PubMed 19632710 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00148408
Lead sponsor
American Lung Association Asthma Clinical Research Centers
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Sep 8, 2005
Start date
Dec 2003
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Apr 30, 2010

Study contacts

Nicholas Anthonisen, MD
study chair · University of Winnipeg
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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