Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
600 participants
INTERVENTIONAL
2003-12-31
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
DOUBLE
Interventions
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Montelukast
Education
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
American Lung Association Asthma Clinical Research Centers
OTHER
Principal Investigators
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Nicholas Anthonisen, MD
Role: STUDY_CHAIR
University of Winnipeg
Locations
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University of Missouri at Kansas City
Kansas City, Missouri, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at San Diego
San Diego, California, United States
National Jewish Hospital
Denver, Colorado, United States
Nemour's Childrens Center
Jacksonville, Florida, United States
University of Miami (and University of South Florida in Tampa)
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Louisiana State University
New Orleans, Louisiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Long Island Jewish Hospital (and North Shore Hospital)
New Hyde Park, New York, United States
New York Consortium (New York Univ. and Columbia Univ.)
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Northern New England Consortium (Univ. of Vermont and other locations)
Burlington, Vermont, United States
Countries
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References
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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.
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.
Related Links
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American Lung Association Asthma Clinical Research Centers
Other Identifiers
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ALAACRC-04
Identifier Type: -
Identifier Source: org_study_id