Trial of Asthma Patient Education (TAPE)

American Lung Association Asthma Clinical Research Centers

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Montelukast; Behavioral: Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00148408

ALAACRC-04

Details and patient eligibility

About

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.

Full 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?

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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