Harvard Clinical Research Institute Initiates Comparative Effectiveness Study to Evaluate Asthma Therapies in Black Patients

    April 12, 2011 12:02 UTC

    Harvard Clinical Research Institute Initiates Comparative
    Effectiveness Study to Evaluate Asthma Therapies in Black Patients

    -Results May Impact Current Treatment Guidelines and Improve
    Patient Care – Second High Profile Public Health Study to be Granted to

    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

    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.


    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)


    MacDougall Biomedical Communications
    Kari Watson, 781-235-3060
    Tromblee, 781-235-3060

    Source: Harvard Clinical Research Institute