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Trial of Asthma Patient Education (TAPE)
This study has been completed.
Sponsor:
American Lung Association Asthma Clinical Research Centers
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:
NCT00148408
First received: September 6, 2005
Last updated: April 28, 2010
Last verified: September 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Asthma | Drug: Montelukast Behavioral: Education | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double-Blind |
| Official Title: | Trial of Asthma Patient Education (TAPE) |
Resource links provided by NLM:
Further study details as provided by American Lung Association Asthma Clinical Research Centers:
Primary Outcome Measures:
- Morning peak expiratory flow
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2003 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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?
Eligibility| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148408
Show 20 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148408
Show 20 Study Locations
Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Study Chair: | Nicholas Anthonisen, MD | University of Winnipeg |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00148408 History of Changes |
| Other Study ID Numbers: |
ALAACRC-04 |
| Study First Received: | September 6, 2005 |
| Last Updated: | April 28, 2010 |
Keywords provided by American Lung Association Asthma Clinical Research Centers:
|
Asthma Placebo Education |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 26, 2017