Trial of Asthma Patient Education (TAPE)

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ClinicalTrials.gov Identifier: NCT00148408

Recruitment Status : Completed

First Posted : September 8, 2005

Last Update Posted : April 30, 2010

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

American Lung Association Asthma Clinical Research Centers

Study Description

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


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

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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 ClinicalTrials.gov identifier (NCT number): 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

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 Key Record Dates
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

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