Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 1:41 PM
Study NCT ID:
NCT01423461
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2011-08-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Asthma Care Team
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-25', 'studyFirstSubmitDate': '2011-08-24', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Asthma', 'Sleep Disordered Breathing', 'Obesity']}, 'descriptionModule': {'briefSummary': '"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.\n\nAsthma, 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 4 to 18 years\n* diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma\n\nExclusion Criteria:\n\n* other severe co-morbidity (cystic fibrosis, sickle cell disease, chronic lung disease of prematurity, interstitial lung disease, cerebral palsy)\n* inability of family to provide informed consent\n* plans of the family to move out of the greater Cleveland area in the subsequent 24 months\n* or inability to participate in regular follow up visits'}, 'identificationModule': {'nctId': 'NCT01423461', 'acronym': 'PACT', 'briefTitle': 'Personalized Asthma Care Team', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Individualized Health Care for Children With Common Chronic Diseases', 'orgStudyIdInfo': {'id': 'L2005-0254'}, 'secondaryIdInfos': [{'id': 'KL2RR024990', 'link': 'https://reporter.nih.gov/quickSearch/KL2RR024990', 'type': 'NIH'}, {'id': 'UL1RR024989', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024989', 'type': 'NIH'}, {'id': '1U54CA116867', 'link': 'https://reporter.nih.gov/quickSearch/1U54CA116867', 'type': 'NIH'}, {'id': 'M01RR000080', 'link': 'https://reporter.nih.gov/quickSearch/M01RR000080', 'type': 'NIH'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susan Redline, M.D., M.P.H.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Kristie Ross, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Meeghan Hart, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Carol Rosen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Foundation', 'class': 'OTHER'}, {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physician, Division of Sleep Medicine', 'investigatorFullName': 'Susan Redline', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}