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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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.
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?
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | |||
| Education | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Morning peak expiratory flow |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry | ||
| Asthma diaries | ||
| Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Anthonisen, MD | University of Winnipeg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26341049 | Derived | Gerald JK, Carr TF, Wei CY, Holbrook JT, Gerald LB. Albuterol Overuse: A Marker of Psychological Distress? J Allergy Clin Immunol Pract. 2015 Nov-Dec;3(6):957-62. doi: 10.1016/j.jaip.2015.06.021. Epub 2015 Sep 1. | |
| 19632710 | Derived | Wise RA, Bartlett SJ, Brown ED, Castro M, Cohen R, Holbrook JT, Irvin CG, Rand CS, Sockrider MM, Sugar EA; American Lung Association Asthma Clinical Research Centers. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. J Allergy Clin Immunol. 2009 Sep;124(3):436-44, 444e1-8. doi: 10.1016/j.jaci.2009.05.041. Epub 2009 Jul 25. |
| Label | URL |
|---|---|
| American Lung Association Asthma Clinical Research Centers | View source |
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| Generic health quality of life (SF-36) |
| Shortness of Breath Questionnaire |
| Adherence monitoring |
| San Diego |
| California |
| 92103 |
| United States |
| National Jewish Hospital | Denver | Colorado | 80206 | United States |
| Nemour's Childrens Center | Jacksonville | Florida | 32207 | United States |
| University of Miami (and University of South Florida in Tampa) | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Missouri at Kansas City | Kansas City | Missouri | 64108 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Long Island Jewish Hospital (and North Shore Hospital) | New Hyde Park | New York | 11040 | United States |
| New York Consortium (New York Univ. and Columbia Univ.) | New York | New York | 10016 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Northern New England Consortium (Univ. of Vermont and other locations) | Burlington | Vermont | 05405 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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