Trial of Asthma Patient Education (TAPE)

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Lung Association Asthma Clinical Research Centers
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Montelukast

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