Trial of Asthma Patient Education (TAPE)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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?

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

American Lung Association Asthma Clinical Research Centers 

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

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.

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.

ClinicalTrials.gov Identifier:	NCT00148408 History of Changes
Other Study ID Numbers:	ALAACRC-04
First Posted:	September 8, 2005
Last Update Posted:	April 30, 2010
Last Verified:	September 2006

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	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