ClinicalTrials.gg
CompletedNCT00281151Updated Dec 11, 2014

Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers

An observational study in Asthma and Lung Diseases, sponsored by Vanderbilt University. Completed at 2 sites in United States. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2014-12-11.

Sponsored by Vanderbilt University · Observational

Study type
Observational
Model
Cohort
Enrollment
180
Ages
Up to 60 Years
Sex
Female
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Study 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.

Read the detailed 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.

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Conditions studied

  • Asthma
  • Lung Diseases
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In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 180 is above the median of 150 across 993 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 520 studies on the registry; 18 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll pregnant women with asthma, children requiring intensive care unit (ICU) admission for asthma, and asthmatics requiring emergency care.

Eligibility criteria

Inclusion Criteria:

  • Pregnant women with asthma
  • Children requiring intensive care unit (ICU) admission for asthma
  • Asthmatics requiring emergency care.
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Study design

Observational model
Cohort
Enrollment
180 participants (actual)
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What researchers measure

Primary outcomes

  1. Asthma related maternal/fetal morbidities and asthma control

    Time frame: Measured between two and six weeks following delivery

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Study locations

2 sites
  • Meharry Medical School
    Nashville, Tennessee 37208, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
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References and documents

Publications

  • 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. PubMed 15901861 ↗
  • 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. PubMed 16780937 ↗
  • 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. PubMed 16631099 ↗
  • 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. PubMed 15994619 ↗
  • 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. PubMed 14710102 ↗
  • 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. PubMed 16652282 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2002, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2006
First posted
Jan 24, 2006
Start
Sep 2002
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Dec 11, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00281151
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University School of Medicine, Meharry Medical College
Responsible party
James Sheller (Professor of Medicine, Vanderbilt University) — Principal investigator
First posted
Jan 24, 2006
Start date
Sep 2002
Primary completion
May 2008
Completion
May 2008
Last update
Dec 11, 2014

Study contacts

James R. Sheller
principal investigator · Vanderbilt University Medical Center
John J. Murray
principal investigator · Meharry Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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