Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00281151
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2006-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2006-01-20', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma related maternal/fetal morbidities and asthma control', 'timeFrame': 'Measured between two and six weeks following delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '15901861', 'type': 'BACKGROUND', 'citation': 'Talbot TR, Hartert TV, Mitchel E, Halasa NB, Arbogast PG, Poehling KA, Schaffner W, Craig AS, Griffin MR. Asthma as a risk factor for invasive pneumococcal disease. N Engl J Med. 2005 May 19;352(20):2082-90. doi: 10.1056/NEJMoa044113.'}, {'pmid': '16780937', 'type': 'BACKGROUND', 'citation': 'Whalen U, Griffin MR, Shintani A, Mitchel E, Cruz-Gervis R, Forbes BL, Hartert TV. Smoking rates among pregnant women in Tennessee, 1990-2001. Prev Med. 2006 Sep;43(3):196-9. doi: 10.1016/j.ypmed.2006.04.021. Epub 2006 Jun 15.'}, {'pmid': '16631099', 'type': 'BACKGROUND', 'citation': 'Enriquez R, Wu P, Griffin MR, Gebretsadik T, Shintani A, Mitchel E, Carroll KN, Hartert TV. Cessation of asthma medication in early pregnancy. Am J Obstet Gynecol. 2006 Jul;195(1):149-53. doi: 10.1016/j.ajog.2006.01.065. Epub 2006 May 2.'}, {'pmid': '15994619', 'type': 'BACKGROUND', 'citation': 'Carroll KN, Griffin MR, Gebretsadik T, Shintani A, Mitchel E, Hartert TV. Racial differences in asthma morbidity during pregnancy. Obstet Gynecol. 2005 Jul;106(1):66-72. doi: 10.1097/01.AOG.0000164471.87157.4c.'}, {'pmid': '14710102', 'type': 'BACKGROUND', 'citation': 'Hartert TV, Neuzil KM, Shintani AK, Mitchel EF Jr, Snowden MS, Wood LB, Dittus RS, Griffin MR. Maternal morbidity and perinatal outcomes among pregnant women with respiratory hospitalizations during influenza season. Am J Obstet Gynecol. 2003 Dec;189(6):1705-12. doi: 10.1016/s0002-9378(03)00857-3.'}, {'pmid': '16652282', 'type': 'BACKGROUND', 'citation': 'Venarske DL, Busse WW, Griffin MR, Gebretsadik T, Shintani AK, Minton PA, Peebles RS, Hamilton R, Weisshaar E, Vrtis R, Higgins SB, Hartert TV. The relationship of rhinovirus-associated asthma hospitalizations with inhaled corticosteroids and smoking. J Infect Dis. 2006 Jun 1;193(11):1536-43. doi: 10.1086/503809. Epub 2006 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the mechanisms underlying the disparities in asthma and to improve asthma care in pregnant women, a targeted group at high risk for asthma-specific maternal and perinatal complications.', 'detailedDescription': "BACKGROUND:\n\nAsthma is a serious chronic condition affecting over 14 million Americans. Data indicate that rates of asthma are higher in certain populations. In fact, African Americans and Hispanics from the Northeast are twice as likely to die from asthma as whites. African Americans are four times as likely to be hospitalized for asthma and are five times more likely than whites to seek care for asthma at an emergency department. Reasons for these higher rates are not certain, and most likely result from an interaction of risk factors such as environmental exposures, genetic predisposition, access to appropriate medical care, socioeconomic status, and cultural health practices. The National Heart, Lung, and Blood Institute (NHLBI) supports a variety of activities to address the pressing public health problems posed by asthma. However, progress in reducing disparities has been disappointingly slow. Separate, independent research projects have generated important clues for understanding the nature and scope of the problem, but a more coordinated, interdisciplinary, and comprehensive approach to research is needed. By fostering partnerships among minority medical centers, research intensive institutions, and the communities in which asthma patients live, cooperative research centers can help increase the capacity to improve health outcomes among minority and economically disadvantaged populations.\n\nDESIGN NARRATIVE:\n\nThis study will comprise three groups: pregnant women with asthma, children requiring intensive care unit (ICU) admission for asthma, and asthmatics requiring emergency care. In one part of the study, researchers will randomly assign pregnant women with asthma of African American or Hispanic race/ethnicity to one of two culturally sensitive asthma education and smoking cessation programs. At the same time, investigators will examine asthma-related morbidity in a large cohort of pregnant asthmatic women utilizing administrative data and vital records. Perceptions of asthma severity and ways to describe it appear to differ in African Americans compared to whites. Therfore, asthmatic patients attending the emergency room, along with their families, will be invited to participate in a focus group to validate a culturally sensitive instrument to allow improved descriptors of asthma severity for African Americans. Estimates by the patients of asthma severity will be matched to objective measure, and compared with those of whites. This methodology will then be used to extend the hypothesis to children admitted with severe asthma to the region's only pediatric ICU. In the pediatric ICU, the admission rates and outcomes will be associated with the potentially important genetic variations in the beta 2 adrenergic receptor (BADR2). Using parents and non-affected siblings as case controls, a novel computational method will test for gene-gene interactions that explain a genetic basis for asthma disparities in severe asthma."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll pregnant women with asthma, children requiring intensive care unit (ICU) admission for asthma, and asthmatics requiring emergency care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with asthma\n* Children requiring intensive care unit (ICU) admission for asthma\n* Asthmatics requiring emergency care.'}, 'identificationModule': {'nctId': 'NCT00281151', 'briefTitle': 'Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers', 'orgStudyIdInfo': {'id': '1198'}, 'secondaryIdInfos': [{'id': 'U01HL072431', 'link': 'https://reporter.nih.gov/quickSearch/U01HL072431', 'type': 'NIH'}, {'id': 'U01HL072471', 'link': 'https://reporter.nih.gov/quickSearch/U01HL072471', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Meharry Medical School', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'James R. Sheller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'John J. Murray', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meharry Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Vanderbilt University School of Medicine', 'class': 'OTHER'}, {'name': 'Meharry Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'James Sheller', 'investigatorAffiliation': 'Vanderbilt University'}}}}