Trial of Asthma Patient Education (TAPE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00148408 |
Recruitment Status :
Completed
First Posted : September 8, 2005
Last Update Posted : April 30, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Montelukast Behavioral: Education | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Official Title: | Trial of Asthma Patient Education (TAPE) |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

- Morning peak expiratory flow
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148408

Study Chair: | Nicholas Anthonisen, MD | University of Winnipeg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00148408 |
Other Study ID Numbers: |
ALAACRC-04 |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | April 30, 2010 |
Last Verified: | September 2006 |
Asthma Placebo Education |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Montelukast |
Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |