Status:
COMPLETED
Trial of Asthma Patient Education (TAPE)
Lead Sponsor:
American Lung Association Asthma Clinical Research Centers
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
15+ years
Phase:
PHASE4
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 subje...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00148408
Start Date
December 1 2003
End Date
December 1 2005
Last Update
April 30 2010
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California at San Diego
San Diego, California, United States, 92103
3
National Jewish Hospital
Denver, Colorado, United States, 80206
4
Nemour's Childrens Center
Jacksonville, Florida, United States, 32207