The AAFP National Research Network, or AAFP NRN, is seeking to recruit as many as 20 family medicine practices for a study that will compare the effectiveness of two different bronchodilating agents -- each in combination with inhaled corticosteroids, or ICSs -- in delaying the time to exacerbation in black patients with asthma.
Compared with other racial and ethnic groups, blacks with asthma have been shown to have poorer control of their asthma. The addition of long-acting beta agonists, or LABAs, to therapy with ICSs(www.nhlbi.nih.gov) in patients whose asthma is inadequately controlled on low-dose ICSs alone has been shown to be effective in reducing asthma symptoms and exacerbations in the general population. However, these agents also have been associated with an increased risk of asthma-related morbidity and mortality(chestjournal.chestpubs.org), particularly in blacks.
It is unclear whether blacks benefit from the addition of an LABA to an inhaled corticosteroid to the same degree as non-blacks, and so it has been difficult to weigh the relative risk of using these agents in this population against the potential benefit. Thus, the Blacks and Exacerbations on LABA vs. Tiotropium, or BELT, study will compare patient outcomes of two groups: one using LABAs and ICSs, and another using a different bronchodilator -- the long-acting anticholingeric tiotropium -- and ICSs.
"Asthma has an increased burden among black children and adults," said co-investigator Barbara Yawn, M.D., MSc., director of research at the Olmsted Medical Center in Rochester, Minn., and adjunct professor of family and community health at the University of Minnesota. "This study is designed to better understand what may be a differential impact of asthma therapies between blacks and non-blacks, allowing us to better tailor asthma therapies."
Each participating practice will be asked to enroll 100 black adults with asthma who meet both of the following conditions:
- less than a 10-year pack history(smokingpackyears.com) of smoking, and
- asthma that is either not controlled on low-dose ICSs or requires combination therapy.
Because one reason black patients may have more trouble controlling their asthma with LABAs is that they are more likely than whites to have a particular genetic variation(www.thelancet.com) known as Arg16Arg, during their baseline visit, patients will be asked to give a saliva sample for genotyping.
Patients will be paid for their yearlong participation in the study.
Each participating practice will be compensated for participation and provided funds to hire a study coordinator who will be responsible for recruiting, enrolling and conducting study visits. The study coordinator and at least one other member of the practice will be trained to use a spirometer and interpret test results. A free laptop and spirometer will be provided to each practice.
The Olmsted Medical Center, Brigham and Women's Hospital Asthma Research Center in Boston, and Harvard Medical School are collaborating in the study, which is funded by the Agency for Healthcare Research and Quality.
Physicians who are interested in participating or who have questions about the study may contact Wilson Pace, M.D., director of the AAFP NRN and professor in the family medicine department at the University of Colorado-Denver, by email or by calling (800) 274-2237, Ext. 3120. Interested physicians also may contact AAFP NRN senior research associate Brian Manning by e-mail or by calling (800) 274-2237, Ext. 3179.