Bacterial trial fails to demonstrate early asthma prevention

A nationwide clinical trial, initiated by researchers at the University of Arizona College of Medicine—Tucson, revealed that an oral bacterial extract called OM-85 failed to reduce the likelihood of severe wheezing and respiratory conditions that could lead to asthma in young children. Published in The Lancet, the study, known as the ORBEX trial, concluded after a decade-long effort.

Led by Dr. Fernando Martinez, director of the asthma and airway disease research center, and Dr. Wayne Morgan, professor of pediatrics and physiology, the research team evaluated the preventive effectiveness of OM-85, also known as Broncho-Vaxom.

The ORBEX trial enrolled 822 at-risk children between 6 and 18 months of age, predominantly those with a family history of asthma or eczema. The treatment, administered to 10 days a month for two years, was designed to evaluate the preventive ability of the bacterial extract against respiratory illnesses that often precede asthma.

The study aimed to determine whether a two-year treatment could prevent severe wheezing—defined as breathing difficulties severe enough to necessitate multiple rescue treatments or oral corticosteroid prescriptions—within three years post treatment and stave off asthma altogether by age 6. However, no significant difference was observed between the groups receiving OM-85 and those receiving a placebo in terms of the onset of first severe wheezing, with 21% of OM-85 recipients experiencing such an episode compared to 18% of the placebo group. Similarly, the incidence of clinical asthma by age 6 was identical between the two groups, at 21%.