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Trial of Asthma Patient Education (TAPE)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:
NCT00148408
First received: September 6, 2005
Last updated: April 28, 2010
Last verified: September 2006
History of Changes
  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
Behavioral: Education
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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?

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148408

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

Additional Information:
American Lung Association Asthma Clinical Research Centers  This link exits the ClinicalTrials.gov site

No publications provided by American Lung Association Asthma Clinical Research Centers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00148408     History of Changes
Other Study ID Numbers: ALAACRC-04
Study First Received: September 6, 2005
Last Updated: April 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by American Lung Association Asthma Clinical Research Centers:
Asthma
Placebo
Education

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013