Trial of Asthma Patient Education (TAPE)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Locations
- 39
- Primary Endpoint
- Morning peak expiratory flow
Study Overview
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- Double
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Morning peak expiratory flow
Secondary Outcomes
- Asthma diaries
- Spirometry
- 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