Clinical trial NCT01423461: Personalized Asthma Care Team
Official title: Individualized Health Care for Children With Common Chronic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Sleep Disordered Breathing
Obesity
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Cleveland Foundation
name: University Hospitals Cleveland Medical Center
name: Case Western Reserve University
name: National Center for Research Resources (NCRR)
name: National Cancer Institute (NCI)
First posted: 2011-08-26
Enrollment: 201
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children seen at the pediatric pulmonology department with a diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma, ages 4 to 18 years will be recruited.

Brief summary: "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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Susan Redline, M.D., M.P.H.
role: STUDY_DIRECTOR
affiliation: University Hospitals Cleveland Medical Center
name: Kristie Ross, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Meeghan Hart, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Carol Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: