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Experts from Children’s Hospital Colorado co-led a team of researchers in studying new approaches to reducing fall asthma exacerbations in pediatric patients. Their findings were released online in late October and published in the December 2015 issue of The Journal of Allergy and Clinical Immunology (JACI), an official scientific journal of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the most-cited journal in the field of allergy and clinical immunology.
Known as the PROSE (Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations) Trial, the study looked at whether or not a preventative strategy of treating patients with omalizumab (Xolair) four to six weeks before the start of school and continuing it for the next four months helped prevent the asthma flare-ups that typically come during the fall season when children return to school, a time known as the September Epidemic of Asthma.
Designed by Dr. Stanley Szefler, director of the Pediatric Asthma Research Program and research medical director of the Breathing Institute at Children's Colorado, the study was led by Dr. Stephen Teach, chair of the Department of Pediatrics at Children's National Health System. Dr. Andrew Liu, allergist and immunologist at Children’s Colorado, was the site manager for the Colorado portion of the study. The study site in Colorado was at National Jewish Health as part of the National Institutes of Allergy and Infectious Diseases Inner City Asthma Consortium. Thanks to the participants, families, staff and support from National Jewish Health in conducting this important study.
The study included 727 participants, ages six to 17 years, who resided in low-income, inner-city areas. It was conducted over two fall cycles, 2012 and 2013. Participants received interventions beyond their regular ongoing treatment beginning four to six weeks prior to the beginning of school and ending 90 days following the start of school.
Study findings indicate that preventative treatment with omalizumab does reduce fall exacerbations in a high-risk group of allergic asthma subjects. This effect was seen most notably in participants who had experienced a recent exacerbation.
The therapy also appears to restore immune protection against common cold viruses that can trigger severe asthma attacks and can be impaired by allergies.
“The results of our study give us an exciting new way to treat pediatric patients with allergic asthma,” said Dr. Szefler. “By identifying those patients who are at high risk for fall asthma exacerbations, we can target directed treatment for them during the times of year that they’re at the greatest risk for problems. In this way, we can better control their asthma and hopefully ultimately limit their treatment duration.”
The researchers also found that increasing inhaled steroid treatment levels above those determined to achieve control offered little to no additional benefit in preventing exacerbations.
Stanley Szefler, MD, has been the Director of Pediatric Asthma Research in the Breathing Institute at Children’s Hospital Colorado since 2013. Before joining Children’s Colorado, Dr. Szefler served as the Head of the Division of Pediatric Clinical Pharmacology at National Jewish Health as well as Director of the Pediatric Clinical Trials Center there. Dr. Szefler has published more than 400 scientific articles and co-edited books on severe asthma, childhood asthma and pediatric allergy and immunology. Dr. Szefler’s dedication to pediatric asthma research brought him to Children's Hospital Colorado where he continues to work on his commitment to new treatment and therapies to improve the care for children with asthma here and around the world.