- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01423461
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Susan Redline, M.D., M.P.H., Brigham and Women's Hospital
- Ledende efterforsker: Kristie Ross, M.D., University Hospitals Cleveland Medical Center
- Ledende efterforsker: Meeghan Hart, M.D., University Hospitals Cleveland Medical Center
- Ledende efterforsker: Carol Rosen, M.D., University Hospitals Cleveland Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Sygdomme i immunsystemet
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Lungesygdomme
- Overfølsomhed, Øjeblikkelig
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Respiratorisk overfølsomhed
- Overfølsomhed
- Søvnapnø syndromer
- Astma
Andre undersøgelses-id-numre
- L2005-0254
- M01RR000080 (U.S. NIH-bevilling/kontrakt)
- KL2RR024990 (U.S. NIH-bevilling/kontrakt)
- UL1RR024989 (U.S. NIH-bevilling/kontrakt)
- 1U54CA116867 (U.S. NIH-bevilling/kontrakt)
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