BOSTON–(BUSINESS WIRE)–
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.¹ 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 2004.²

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.³ 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.⁴ Hospitalization rates for asthma are
almost 2.5 times greater in Blacks than in Caucasians.⁵ Even
more alarming, the death rate is 165 percent higher in Blacks than it is
in Caucasians.⁶

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.

www.hcri.harvard.edu

¹ (Akinbami 2006)

² (ALA 2007)

³ (Akinbami 2006).

⁴ (Eisner 2001; Adams 2000; Griswold 2005; El-Ekiaby 2006)

⁵ (Akibami 2006)

⁶ (Akibami 2006)