Trial of Asthma Patient Education (TAPE)

This study has been completed.

First Received on September 6, 2005. Last Updated on April 28, 2010 History of Changes

Sponsor:	American Lung Association Asthma Clinical Research Centers
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:	NCT00148408

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 IV

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

Drug Information available for: Montelukast sodium Montelukast

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):

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. Epub 2009 Jul 25.

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 February 09, 2012