Clinical trial NCT00148408: Trial of Asthma Patient Education (TAPE)
Official title: Trial of Asthma Patient Education (TAPE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Placebo
Education
Lead sponsor: American Lung Association Asthma Clinical Research Centers
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-08
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

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 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

Primary outcomes:
measure: Morning peak expiratory flow
Secondary outcomes:
measure: Spirometry
measure: Asthma diaries
measure: Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life)
measure: Generic health quality of life (SF-36)
measure: Shortness of Breath Questionnaire
measure: Adherence monitoring
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Denver
country: United States
facility: National Jewish Hospital
state: Colorado
city: Jacksonville
country: United States
facility: Nemour's Childrens Center
state: Florida
city: Miami
country: United States
facility: University of Miami (and University of South Florida in Tampa)
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: University of Missouri at Kansas City
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New Hyde Park
country: United States
facility: Long Island Jewish Hospital (and North Shore Hospital)
state: New York
city: New York
country: United States
facility: New York Consortium (New York Univ. and Columbia Univ.)
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Burlington
country: United States
facility: Northern New England Consortium (Univ. of Vermont and other locations)
state: Vermont
Study officials:
affiliation: University of Winnipeg
name: Nicholas Anthonisen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.