AsthmaPACTNCT01423461
Personalized Asthma Care Team
An observational study of Asthma and Sleep Disordered Breathing, run by Brigham and Women's Hospital.
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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Asthma, Sleep Disordered Breathing, Obesity
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- ages 4 to 18 years
- diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Asthma, Sleep Disordered Breathing, Obesity
- Medical subject headings
- Asthma, Sleep Apnea Syndromes, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJul 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Susan Redline, Brigham and Women's Hospital
- Investigators
- Susan Redline, M.D., M.P.H., Study director, Brigham and Women's HospitalKristie Ross, M.D., Principal investigator, University Hospitals Cleveland Medical CenterMeeghan Hart, M.D., Principal investigator, University Hospitals Cleveland Medical CenterCarol Rosen, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423461
- Sponsor's protocol ID
- L2005-0254
- Other IDs
- KL2RR024990, UL1RR024989, 1U54CA116867, M01RR000080
- Acronym
- PACT
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Health Care for Children With Common Chronic Diseases
- ClinicalTrials.gov ID
- NCT01423461
- Acronym / sponsor ID
- PACT / L2005-0254
- Conditions
- Asthma, Sleep Disordered Breathing, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Cleveland Foundation, University Hospitals Cleveland Medical Center, Case Western Reserve University, National Center for Research Resources (NCRR), National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- ages 4 to 18 years
- diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
Related trials for Asthma
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Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Sleep Disordered Breathing, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.