Back-to-School Drug Treatment May Curb Fall Asthma Epidemic

New clinical trial results have identified the drug omalizumab helps reduce the severity of asthma flare-ups during the autumn back–to-school transition, known as the “September Epidemic of Asthma.”

The clinical trial, called Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE), took place between 2012 and 2014, and enrolled 727 children and adolescents (ages 6 to 17 years) at 8 urban research facilities. The study was part of the Inner-City Asthma Consortium, which is an asthma research program funded by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health.

In the study, the drug was given to participants alone, or in tandem with inhaled corticosteroid (ICS) treatment. Starting 4 to 6 weeks before the first day of school and ending 90 days later, the study found that when injections of omalizumab were administered every 2 to 4 weeks during the epidemic season, the incidence of flare-ups significantly decreased by more than 80% among a study group of young urban asthma sufferers. These flare ups—which the study investigators called exacerbations—involved a sudden and intense outbreak in asthma-related symptoms that led to corticosteroid treatment or hospitalization.

Patients in the study group that received the run-in omalizumab treatment also reported nearly half as many days with asthma-related symptoms during the study period than they did before treatment began (2.3 vs. 4.5 days). There was no significant difference in seasonal exacerbations when the drug treatment group was compared with the drug + ICS treatment group.

 "The results of our study give us an exciting new way to treat pediatric patients with allergic asthma,” said Stanley Szefler, director of the Pediatric Asthma Research Program at Children’s Hospital Colorado. "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 results are significant because asthma is the leading cause of missed school days and childhood hospitalizations in United States., according to the CDC.

“The findings from this study open the door for a targeted, effective treatment approach for some of our most vulnerable asthma patients,” said Rebecca Gruchalla, professor of internal medicine and pediatrics at the University of Texas Southwestern Medical Center, and co-author of the study.

The complete study was published in the December 2015 issue of the Journal of Allergy and Clinical Immunology.

—Drew Amorosi

Reference:

Teach SJ, Gill MA, Togias A, et al. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol. 2015;136(6):1476-1485.