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
201 participants
OBSERVATIONAL
2005-07-31
2009-12-31
Brief Summary
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Asthma, an inflammatory disorder of the airway, appears to be determined by multiple interacting genetic and environmental factors. Such risk factors include allergic responses, small airways, excess body weight, specific properties of airway smooth muscle, airway and generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants, allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided by "severity" guidelines rather than by characteristics of the child's specific phenotype (a child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle dysfunction, or underlying obesity and metabolic perturbations). The growing availability of new classes of asthma medications that more directly target specific pathophysiological derangements will require accessing data on each child's asthma risk profiles to optimize selection of medications and other interventions that most specifically address the underlying pathophysiology while minimizing adverse treatment side effects.
The investigators propose to develop a model program for collecting relevant clinical information and genetic data on a high risk group of asthmatic children, including data on common co-morbidities, specifically obesity and sleep disorders; use this information to develop a comprehensive model database for characterizing children according to their health profiles; and use this characterization to initiate targeted interventions, while continuing long term follow up of these children to determine differential responsiveness to medications.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma
Exclusion Criteria
* inability of family to provide informed consent
* plans of the family to move out of the greater Cleveland area in the subsequent 24 months
* or inability to participate in regular follow up visits
4 Years
18 Years
ALL
No
Sponsors
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The Cleveland Foundation
OTHER
University Hospitals Cleveland Medical Center
OTHER
Case Western Reserve University
OTHER
National Center for Research Resources (NCRR)
NIH
National Cancer Institute (NCI)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Susan Redline
Senior Physician, Division of Sleep Medicine
Principal Investigators
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Susan Redline, M.D., M.P.H.
Role: STUDY_DIRECTOR
Brigham and Women's Hospital
Kristie Ross, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Meeghan Hart, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Carol Rosen, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Other Identifiers
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L2005-0254
Identifier Type: -
Identifier Source: org_study_id
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