BOSTON - April 12, 2011 - The Harvard Clinical Research Institute (HCRI) announced today that it has begun enrolling patients into the BELT (Blacks and Exacerbations on LABA vs. Tiotropium) Study, the purpose of which is to investigate whether Black patients with asthma are more likely to experience adverse outcomes as a result of long-acting beta-agonist (LABA) therapy. The BELT study was funded by a grant from the Agency for Healthcare Research and Quality (AHRQ). The principal investigator of the study is Dr. Elliot Israel, the Director of Clinical Research in the Pulmonary Division at Brigham and Women's Hospital in Boston.
"At HCRI we thrive on projects that will help answer some of the most difficult questions facing our healthcare system today," said Spencer Goldsmith, President of HCRI. "This is the second high-profile public health study we have been granted, and we are pleased that we have been able to work so closely with groups like the AHRQ and the FDA in order to tackle large-scale healthcare discrepancies and answer pressing questions with regard to improving treatment guidelines."
"Studies have suggested that LABAs may not be as effective in Blacks and that there may be a genetic sub-population in whom the response is even lower," said Dr. Israel. "This study will help us amend, if necessary, the current treatment guidelines so that better care is provided to this patient population."
Current asthma treatment guidelines recommend prescribing a LABA in addition to an inhaled corticosteroid controller medication (ICS) in those patients who are not completely controlling their symptoms on ICS alone. These recommendations are based on studies on the overall benefit demonstrated in the general population; however, they do not take into consideration a risk-benefit analysis with regard to serious adverse events, particularly in specific patient populations such as Blacks.
Drugs acting on the beta-2 adrenergic receptor (ADRB2), including LABAs, have been associated with rare loss of long-term asthma control and increased serious adverse outcomes including death and respiratory failure, possibly even when used with ICS. The risk appears four to five fold greater in Blacks compared to non-Black patients with asthma.
Under the American Recovery and Reinvestment Act of 2009, AHRQ received $1.1 billion in funding to support comparative effectiveness studies that can provide evidence-based information to help physicians make more informed decisions on behalf of patients. Of the total, $300 million is for AHRQ to build on its existing collaborative and transparent Effective Health Care Program.
Asthma Morbidity is Increased in Blacks
Asthma has been designated a priority condition of the Effective Health Care Program. It
produces a significant amount of morbidity. Asthma produces 500,000 hospital admissions and
accounts for 10.1 million days of lost work in adults annually.[i] It accounts for one-fourth of all emergency room visits in the United States. The total cost of asthma was estimated at $14.7 billion of direct costs and $19.7 billion of total costs in 2004.[ii]
Blacks bear a disproportionate burden of the morbidity of asthma compared to Caucasians.
As reported by the Centers for Disease Control, they experience more urgent care visits, higher
rates of hospitalizations and higher death rates.[iii] The asthma attack prevalence rate of Blacks is reported to be 19.2 percent higher than the rate of Caucasians with even higher rates of hospitalizations and emergency room visits.[iv] Hospitalization rates for asthma are almost 2.5 times greater in Blacks than in Caucasians.[v] Even more alarming, the death rate is 165 percent higher in Blacks than it is in Caucasians.[vi]
Dr. Elliot Israel
Dr. Elliot Israel is the Director of Clinical Research in the Pulmonary Division at Brigham and Women's Hospital in Boston. He is board certified in allergy and immunology and in critical care in addition to his board certification in pulmonary disease. His outpatient practice concentrates on patients with asthma with a particular interest in patients with severe asthma.
Dr. Israel's research interests center on clinical trial and translational research aimed at optimizing asthma pharmacotherapy and defining asthma pathobiology, especially as it relates to airway inflammation. He has been particularly interested in the role of eicosanoids in asthma, severe asthma and asthma pharmacogenetics. His research helped define the role for leukotriene modifiers in the treatment of asthma. He has several grants from the National Institutes of Health related to asthma. He leads one of the nine sites throughout the country supported by the NIH to conduct research to define optimal asthma therapy.
His teaching accomplishments were recognized when he was honored with the Daniel D. Federman Outstanding Clinical Educator Award of Harvard Medical School.
BELT Study Protocol and Collaborators
The BELT study (Blacks and Exacerbations on LABA vs. Tiotropium) is a 12-month prospective, randomized, parallel group, open-label, real world effectiveness trial comparing the effectiveness of LABA/ICS vs. tiotropium/ICS in delaying the time to exacerbation in Black patients with asthma. The study will enroll 1,500 patients.
Study protocol and patient eligibility information are available on www.clinicaltrials.gov.
Dr. Israel and the Harvard Clinical Research Institute are collaborating on this study with research groups across the country. The co-investigators are Dr. Michael Wechsler, Associate Physician in Pulmonary and Critical Care at Brigham and Women's Hospital in Boston, Dr. Barbara Yawn, Director of Research at the Olmsted Medical Center in Rochester, Minnesota and Dr. Wilson Pace of the American Academy of Family Physicians National Research Network in Leawood, Kansas.
"Personalizing asthma therapy is one of the key goals of the BELT study," said Wechsler. "Blacks bear a disproportionate amount of asthma's overall burden, and it is critical for us to understand which therapies are best for this population as well as the factors that result in differential responses between Blacks and other patient populations."
About The Harvard Clinical Research Institute (HCRI)
The Harvard Clinical Research Institute is a non-profit academic research organization with unparalleled access to resources in clinical research. The Institute advances the research of pharmaceutical, biological, and medical device products by developing collaborations between industry and academia. HCRI's partners include leading medical centers with worldwide recognition for high-quality medical care and state-of-the-art facilities. Its close affiliation with Harvard Medical School, Beth Israel Deaconess Medical Center and Partners HealthCare reinforces HCRI's commitment to engaging distinguished medical practitioners in thought-provoking, industry-sponsored research. The Institute's sponsors rely on its scientific objectivity to add unique value to the design of their studies, oversight of their research and analysis of their study data. As a leading provider of clinical trial services, HCRI plays an important role in assessing new products that improve the quality of peoples' lives.