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Study Finds Omalizumab Relieves Seasonal Asthma Attacks in Youth

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A drug that targets the antibody immunoglobulin E (IgE), a key player in asthma, nearly eliminated seasonal increases in asthma attacks and decreased asthma symptoms among young people living in inner city environments, a clinical trial sponsored by the National Institutes of Health has found. The findings are published in the New England Journal of Medicine.

This investigational use of the drug omalizumab, sold under the brand name Xolair®, was conducted in eight U.S. cities by the Inner City Asthma Consortium, a nationwide clinical trials network supported by the National Institute of Allergy and Infectious Diseases, part of NIH.

Omalizumab is approved in the United States for people ages 12 and older with moderate to severe persistent allergic asthma.

“We know that treatment based on NIH asthma guidelines is generally effective in managing the disease, but many patients still experience asthma attacks requiring visits to emergency rooms and hospitalizations,” says NIAID Director Anthony S. Fauci, MD. “The results of this study are extremely promising because they show that the addition of omalizumab to the NIH guidelines-based therapy for asthma offers improved asthma control and the potential to decrease the burden of this chronic disease in children and adolescents.”

The investigators found that, overall, children and adolescents who received omalizumab had a 25 percent reduction in days with symptoms and a 30 percent reduction in asthma attacks compared with those who received placebo. Those who received omalizumab also had a 75 percent reduction in hospitalizations. Importantly, the spring and fall increases in asthma attacks that were seen in the participants receiving placebo were almost eliminated in those participants receiving omalizumab.

Children and adolescents who responded the best to omalizumab had positive skin tests for cockroach allergy and high levels of cockroach allergen in their homes. In previous work by NIAID-supported researchers, the combination of cockroach allergy and exposure to cockroaches was found to be an important cause of asthma-related illness and hospitalization.

Omalizumab is a humanized monoclonal antibody, a pure form of a single protein, custom-made for use in humans, which binds to and blocks the activity of IgE, an important molecule in allergy. Omalizumab is approved in the United States for people ages 12 and older with moderate to severe persistent allergic asthma. The drug is jointly developed by Genentech Inc., a member of the Roche group, under an agreement with Novartis Pharma AG. For more information about omalizumab, visit


This article was originally published in Coping® with Allergies & Asthma magazine, Spring/Summer 2011.