CClinicalTrials.gg
CompletedNCT01423461PACTUpdated Aug 26, 2011

Personalized Asthma Care Team

An observational study in Asthma, Sleep Disordered Breathing and Obesity, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2011-08-26.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
201
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma
  • Sleep Disordered Breathing
  • Obesity
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 201 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
201 participants (actual)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01423461
Lead sponsor
Brigham and Women's Hospital
Collaborators
The Cleveland Foundation, University Hospitals Cleveland Medical Center, Case Western Reserve University, National Center for Research Resources (NCRR), National Cancer Institute (NCI)
Responsible party
Susan Redline (Senior Physician, Division of Sleep Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Aug 26, 2011
Start date
Jul 2005
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Aug 26, 2011

Study contacts

Susan Redline, M.D., M.P.H.
study director · Brigham and Women's Hospital
Kristie Ross, M.D.
principal investigator · University Hospitals Cleveland Medical Center
Meeghan Hart, M.D.
principal investigator · University Hospitals Cleveland Medical Center
Carol Rosen, M.D.
principal investigator · University Hospitals Cleveland Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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