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Trial of Asthma Patient Education (TAPE)

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
American Lung Association Asthma Clinical Research Centers Identifier:
First received: September 6, 2005
Last updated: April 28, 2010
Last verified: September 2006
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 Behavioral: Education Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Official Title: Trial of Asthma Patient Education (TAPE)

Resource links provided by NLM:

Further study details as provided by American Lung Association Asthma Clinical Research Centers:

Primary Outcome Measures:
  • Morning peak expiratory flow

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

Estimated Enrollment: 600
Study Start Date: December 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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?

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00148408

  Show 20 Study Locations
Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Nicholas Anthonisen, MD University of Winnipeg
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00148408     History of Changes
Other Study ID Numbers: ALAACRC-04
Study First Received: September 6, 2005
Last Updated: April 28, 2010

Keywords provided by American Lung Association Asthma Clinical Research Centers:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017