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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

September 6, 2005
September 8, 2005
April 30, 2010
December 2003
December 2005   (Final data collection date for primary outcome measure)
Morning peak expiratory flow
Same as current
Complete list of historical versions of study NCT00148408 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
Trial of Asthma Patient Education (TAPE)
Trial of Asthma Patient Education (TAPE)
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.
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?
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Asthma
  • Drug: Montelukast
  • Behavioral: Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
Same as current
December 2005
December 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00148408
ALAACRC-04
Not Provided
Not Provided
Not Provided
Not Provided
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Nicholas Anthonisen, MD University of Winnipeg
American Lung Association Asthma Clinical Research Centers
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP