Personalized Asthma Care Team

Obesity Clinical Trial

— PACT  

Official title:

Individualized Health Care for Children With Common Chronic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423461
• Other study ID #: L2005-0254
• Secondary ID: KL2RR024990UL1RR
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: August 25, 2011
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Obesity
• Sleep Disordered Breathing

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Case Western Reserve University, National Cancer Institute (NCI), National Center for Research Resources (NCRR), The Cleveland Foundation, University Hospital Case Medical Center