UT Southwestern Medical Center is one of a handful of top research institutions evaluating a promising new medication researchers hope can reduce the severity and frequency of asthma attacks in inner-city children, a population known to have a high prevalence of severe asthma.
"Children living in inner cities are exposed to higher allergen levels and tend to have more severe asthma than children living elsewhere," said Dr. Rebecca Gruchalla, chief of allergy at UT Southwestern. "We want to see whether this new treatment can help children with allergic asthma, for which the environmental factors are more difficult to control."
Indoor allergens commonly found in inner cities, such as dust mites, cockroaches, molds and animal dander, are significant allergens that may contribute to the severity of a child's asthma. UT Southwestern, along with 10 other sites around the country, is participating in a National Institutes of Health-supported evaluation of anti-IgE therapy for children. This therapy is already being used successfully in adults and adolescents who have asthma.
"IgE antibodies are the fuel in the immune system that perpetuates the asthmatic reaction," said Dr. Gruchalla, serves as principal investigator at the Dallas site. Some people are more genetically prone to develop IgE antibodies, which are molecules produced by white blood cells in response to exposure to allergens. IgE antibodies can make asthma worse in those people who are sensitive to particular allergens.
The Inner City Anti-IgE Therapy for Asthma (ICATA) study involves about 50 children at each site. It will evaluate Xolair (omalizumab), a drug that binds to and inactivates IgE antibodies.
"Xolair 'sops up' the IgE that's there, decreases the receptors for IgE, and regulates many things that pertain to allergy and the asthmatic response," Dr. Gruchalla said.
The two-year Dallas portion of the study targets children 6 to 20 years old who reside within the Dallas Independent School District. Individuals interested in participating should call 214-648-5436 for additional requirements and information.
Participating children will receive an injection every two or four weeks and medical care for their asthma for nearly two years. Laboratory analyses of biological and environmental samples from the home also will occur during the same time period.
The $15 million study is funded through the Inner-City Asthma Consortium (ICAC), an NIH-sponsored, $55.8 million, six-year contract to investigate treatments and causes of asthma in urban children. Novartis Pharmaceuticals Corp. and Genentech, which are providing about $8 million toward the study, are also donating an additional $6 million in medication. The balance of funding will be provided by the National Institute of Allergy and Infectious Diseases.
The consortium is administered by the University of Wisconsin-Madison. Other research sites in addition to UT Southwestern are: the University of Arizona, Boston University, Children's Memorial Hospital in Chicago, Rainbow Babies and Children's Hospital in Cleveland, Children's National Medical Center in Washington, D.C., National Jewish Medical and Research Center in Denver, Johns Hopkins University, Mount Sinai School of Medicine, and St. Louis Children's Hospital.
Dr. Gruchalla has led the Dallas arm of the Inner City Asthma Consortium for four years. She is also principal investigator of an asthma screening project in Dallas schools and project director for Community Leadership in Preventing Asthma, a study evaluating links between asthma-associated morbidity and allergen levels in schools and homes.
Other UT Southwestern investigators in the ICATA study are Dr. William Neaville, clinical assistant professor of pediatrics and internal medicine, and Dr. Vanthaya Gan, clinical professor of pediatrics.