Personalized Asthma Care Team (PACT)

Individualized Health Care for Children With Common Chronic Diseases

"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.

Study Overview

• Status: Completed
• Conditions: Obesity; Asthma; Sleep Disordered Breathing

• Study Type: Observational
• Enrollment (Actual): 201

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Cancer Institute (NCI); University Hospitals Cleveland Medical Center; National Center for Research Resources (NCRR); Case Western Reserve University; The Cleveland Foundation
• Investigators: Study Director: Susan Redline, M.D., M.P.H., Brigham and Women's Hospital; Principal Investigator: Kristie Ross, M.D., University Hospitals Cleveland Medical Center; Principal Investigator: Meeghan Hart, M.D., University Hospitals Cleveland Medical Center; Principal Investigator: Carol Rosen, M.D., University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): August 26, 2011
• Last Update Submitted That Met QC Criteria: August 25, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Sleep Apnea Syndromes; Asthma
• Other Study ID Numbers: L2005-0254; M01RR000080 (U.S. NIH Grant/Contract); KL2RR024990 (U.S. NIH Grant/Contract); UL1RR024989 (U.S. NIH Grant/Contract); 1U54CA116867 (U.S. NIH Grant/Contract)