Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT02574351
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2013-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of T-Regulatory Cells in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'T regulatory cells are isolated in the blood specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.', 'detailedDescription': 'The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.\n\nThis is an exploratory study to investigate the following:\n\n1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.\n2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females in good health between the ages of 18-50, with or without asthma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Obese asthmatics\n2. Normal weight asthmatics\n3. Healthy obese\n4. Health non-obese\n\nAsthmatic subjects will be recruited:\n\n1. If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).\n2. If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.\n\nNon asthmatic subjects\n\n1. Will not have had a prior diagnosis of asthma,\n2. Have no history of atopy.\n3. Have no history of lung diseases.\n\nExclusion Criteria:\n\n1. \\> 10 pack year smoking history, or currently smoking\n2. Pulmonary disease other than asthma.\n3. History of heart disease\n4. Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.\n5. Any agents that could potentially alter the inflammatory system such as thiazolidinedione, a statin, or oral steroid therapy.'}, 'identificationModule': {'nctId': 'NCT02574351', 'briefTitle': 'Study of T-Regulatory Cells in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Study of T-Regulatory Cells in Asthma', 'orgStudyIdInfo': {'id': '11-076B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese asthmatic', 'description': 'Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.', 'interventionNames': ['Biological: blood draw, breathing test']}, {'label': 'normal asthmatic', 'description': 'Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group', 'interventionNames': ['Biological: blood draw, breathing test']}, {'label': 'obese control', 'description': 'Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.', 'interventionNames': ['Biological: blood draw, breathing test']}, {'label': 'normal control', 'description': 'Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.', 'interventionNames': ['Biological: blood draw, breathing test']}], 'interventions': [{'name': 'blood draw, breathing test', 'type': 'BIOLOGICAL', 'description': 'A blood draw,breathing test will be performed on every participant', 'armGroupLabels': ['normal asthmatic', 'normal control', 'obese asthmatic', 'obese control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore LIJ Health System', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Rubin Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}