Recognizing that asthma severity in inner-city children is disproportionately high, NIAID has sponsored research to reduce the public health burden that asthma presents in inner-city populations. Beginning in 1991, NIAID has supported three consecutive inner-city asthma research programs, which have been successful in reducing asthma severity in children.
Credit:NIAID
Timeline of NIAID-supported inner-city asthma programs.
National Cooperative Inner-city Asthma Study (NCICAS) 1991 – 1996
The goal of NCICAS was to identify the environmental factors responsible for asthma in inner-city children and then to develop an intervention strategy based on the findings. NCICAS researchers determined that cockroach allergen in the inner city was directly related to asthma severity. Asthma counselors educated the family on how to reduce this allergen in the home, which helped to reduce the child’s asthma symptoms.
Inner-city Asthma Study (ICAS) 1996 – 2001
The goal of ICAS was to design and conduct an environmental intervention study to reduce the exposure of children with asthma to house dust mites, second-hand smoke, cockroaches, pets, rodents, and mold. The study showed that by reducing environmental allergens, especially in the bedroom, there was a significant reduction in asthma morbidity in at-risk children.
Inner-city Asthma Consortium (ICAC): Phase I (2002 – 2009) and Phase II (2009 – 2014)
The goals of ICAC are to design and implement immune-based therapies for asthma and to conduct studies to define the disease in inner-city children.
Two clinical trials initiated during phase I of ICAC have yielded important results and insights:
In the Asthma Control Evaluation study, investigators divided 500 inner-city adolescents with asthma into two groups: one group received treatment based solely on clinical guidelines of asthma management, while the treatment of the other group was based on the clinical guidelines plus the measurement of exhaled nitric oxide, which is a biomarker of lung inflammation. In the latter group, asthma treatment was modified based on whether the nitric oxide level was high or low. After the year-long study, investigators demonstrated that the addition of a biomarker to modify guidelines-based therapy did not improve management. However, the results of the study clearly demonstrated that asthma, even in inner-city populations, can be well controlled using current asthma treatment guidelines.
In the Inner City Anti-IgE Therapy for Asthma (ICATA) trial, investigators followed 419 inner-city children and adolescents with moderate to severe allergic asthma, who were receiving NIH guidelines-based asthma therapy to control their disease. Half of the participants received omalizumab, a monoclonal antibody that targets the antibody immunoglobulin E (IgE), and the other half received placebo. After a 60-week period, omalizumab plus guidelines base therapy improved asthma control more than just guidelines-based therapy. The fall and spring increases in asthma attacks seen in the participants receiving placebo were almost eliminated in those participants receiving omalizumab. Participants who were both sensitized and exposed to cockroach allergen especially benefited from this intervention.
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, Gruchalla RS, Kattan M, Teach SJ, Pongracic JA, Chmiel JF, Steinbach SF, Calatroni A, Togias A, Thompson KM, Szefler SJ, Sorkness CA. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 364(11):1005-15 (2011).
William Busse, M.D., the principal investigator of ICAC I and II, provides an overview of the contributions of NCICAS, ICAS, and ICAC I to the study of asthma in the inner city and looks ahead to the projects planned under ICAC II.
ICAC investigators are currently conducting several projects focused on improving asthma treatment, including the following:
An observational study to examine the genetic, environmental, and immune system aspects that play a role in the development of asthma in inner-city children by closely following a cohort of more than 500 children from before birth until age 7
An exploration of the use of cockroach extract administered orally under the tongue—called sublingual immunotherapy (SLIT)—as a potential treatment for asthma
A study to examine whether children with asthma have epigenetic differences from children with no asthma or allergies
A follow-on clinical trial (based on the results of the ICATA trial) using omalizumab during the fall to examine if this will eliminate the seasonal increase in asthma exacerbations
Participating ICAC II Sites
ICAC is composed of nine clinical and two basic research sites under the leadership of William Busse, M.D., of the University of Wisconsin-Madison. The nine clinical sites and principal investigators include
Boston University School of Medicine—George O’Connor, M.D.
Children's Hospital Medical Center, Cincinnati—Gurjit Khurana Hershey, M.D., Ph.D.
Children’s Memorial Hospital, Chicago—Jacqueline Pongracic, M.D.
Columbia University College of Physicians and Surgeons, New York City—Meyer Kattan, M.D.
George Washington University School of Medicine and Health Sciences, Washington, DC—Stephen Teach, M.D., M.P.H.
Henry Ford Hospital, Detroit—Edward Zoratti, M.D.
Johns Hopkins University School of Medicine, Baltimore—Robert Wood, M.D.
National Jewish Health, Denver—Andrew Liu, M.D.
University of Texas Southwestern Medical Center, Dallas—Rebecca Gruchalla, M.D., Ph.D.
The two basic research sites and principal investigators include
University of California, San Francisco—Homer Boushey, M.D.
University of Colorado, Denver—David Schwartz, M.D.
Rho, Inc., in Chapel Hill, North Carolina, led by Herman Mitchell, Ph.D., is the statistical and data coordinating center that supports the efforts of the ICAC program.