Personalized Asthma Care Team

NCT ID: NCT01423461

Last Updated: 2011-08-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-12-31

Brief Summary

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"Individualized health care" refers to the development of strategies for disease management and health promotion that are informed by specific data on genetics and physiological processes that uniquely determine each person's health profile and potential responsiveness to interventions or susceptibility to environmental exposures.

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.

Detailed Description

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Conditions

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Asthma Sleep Disordered Breathing Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ages 4 to 18 years
* diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma

Exclusion Criteria

* other severe co-morbidity (cystic fibrosis, sickle cell disease, chronic lung disease of prematurity, interstitial lung disease, cerebral palsy)
* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Foundation

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Redline

Senior Physician, Division of Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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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KL2RR024990

Identifier Type: NIH

Identifier Source: secondary_id

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UL1RR024989

Identifier Type: NIH

Identifier Source: secondary_id

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1U54CA116867

Identifier Type: NIH

Identifier Source: secondary_id

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M01RR000080

Identifier Type: NIH

Identifier Source: secondary_id

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L2005-0254

Identifier Type: -

Identifier Source: org_study_id

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