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Trial of Asthma Patient Education (TAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148408
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 30, 2010
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
American Lung Association Asthma Clinical Research Centers

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast Behavioral: Education Phase 4

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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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Official Title: Trial of Asthma Patient Education (TAPE)
Study Start Date : December 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Primary Outcome Measures :
  1. Morning peak expiratory flow

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148408

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Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
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Study Chair: Nicholas Anthonisen, MD University of Winnipeg
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00148408    
Other Study ID Numbers: ALAACRC-04
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: September 2006
Keywords provided by American Lung Association Asthma Clinical Research Centers:
Additional relevant MeSH terms:
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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