Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers

Asthma Clinical Trial

Official title:

Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281151
• Other study ID #: 1198
• Secondary ID: U01HL072431U01HL
• Status: Completed
• Phase: N/A
• First received: January 20, 2006
• Last updated: December 10, 2014
• Start date: September 2002
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

BACKGROUND:

Asthma 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.

DESIGN NARRATIVE:

This 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• Pregnant women with asthma

• Children requiring intensive care unit (ICU) admission for asthma

• Asthmatics requiring emergency care.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Locations

Country	Name	City	State
United States	Meharry Medical School	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
Vanderbilt University	Meharry Medical College, National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Epub 2006 May 2. — View 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. — View 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. — View 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. Epub 2006 Apr 27. — View 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. Epub 2006 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma related maternal/fetal morbidities and asthma control		Measured between two and six weeks following delivery	No

External Links

•   Click here for the Meharry/Vanderbilt Asthma Disparities Center Web site