Washington, DC – Stephen J. Teach, MD, MPH, Medical Director and Principal Investigator of IMPACT DC, a program of pediatric asthma care and research at Children's National Medical Center, served as the Site Principal Investigator for a new study that may advance asthma treatment and outcomes, specifically for inner-city children and teens. Findings from a clinical trial sponsored by the National Institutes of Health (NIH) were published and released in the March 17 issue of the New England Journal of Medicine.
As noted in the NIH announcement, the investigational use of the drug omalizumab, sold under the brand name Xolair, was conducted in eight US cities by the Inner City Asthma Consortium (ICAC), a nationwide clinical trials network supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Additional support for this research was provided by the NIH National Center for Research Resources and Novartis Pharmaceuticals Corporation.
"This Consortium is an important force in defining best practices in asthma care for at-risk children and adolescents across multiple institutions and regions," said Dr. Teach. "Through our collaborations, we can be more certain that specific institutional and regional factors are not affecting our findings. The goal is to advance universal best practices."
Dr. Teach was one of eight investigators, led by William Busse, MD, the principal investigator of ICAC and professor of medicine at the University of Wisconsin-Madison.
The study enrolled 419 children and youths, ages 6 to 20 years old, diagnosed with moderate to severe allergic asthma lasting more than one year. The children were from Boston, Chicago, Cleveland, Dallas, Denver, New York City, Tucson, Ariz. and Washington, D.C. Nearly all were minorities, including African Americans (60 percent) and Hispanics (37 percent).
The study goal was to determine if adding omalizumab to NIH guidelines-based asthma therapy reduced the number of days that participants experienced any asthma-related symptoms. Another goal was to find out if the addition of omalizumab could also reduce the number of severe asthma attacks. Half of the participants were assigned at random to receive omalizumab, and the other half a placebo.
"The spike in asthma attacks in the fall, which is associated with colds and other viral airway infections, disappeared in the kids in the omalizumab group," said Dr. Busse. "Because the drug specifically targets IgE, which is the antibody responsible for allergies, our observations show the possible interplay between allergies, respiratory viruses and IgE in provoking asthma attacks."
Seasonal asthma attacks can cause children and teens to miss school, particularly in the fall and spring. Additionally, many hospital emergency departments see a spike in visits with severe seasonal asthma flare ups.
"If the ICAC now collaborates in refining indications for use of this drug, we may find the optimal way to use this therapy to reduce emergency department visits and to improve these kids' quality of life," said Dr. Teach. "This is what we mean by translational research – we moved this drug from the laboratory to the patients, found important impacts on kids' lives, and now will work further to develop the best applications. The next step for the ICAC is to focus more closely on the role of omalizumab in reducing fall exacerbations of asthma."
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Journal
New England Journal of Medicine