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| |  ICP: OM-85 Reduces Cumulative Infection Rate In Children With Recurrent Respiratory Tract Infections By Andrew Bowser Special to DG News
BEIJING, CHINA -- September 13, 2001 -- In children with recurrent upper respiratory tract infections, administering the bacterial extract OM-85 BV reduces the cumulative rate of acute infections. These benefits are obtained when the drug is administered intermittently for five months, according to a soon-to-be-published study presented yesterday (September 12) at the 23rd International Congress of Pediatrics in Beijing, China. "'These beneficial effects were observed two months after starting treatment with OM-85, confirming the interest of early treatments, for example, beginning in early autumn," said Dr. Urs B. Schaad, chief physician, Pediatric University Clinic, Basel Children’s Hospital, Switzerland. OM-85 (Broncho-Vaxom, Pharma-Westen GmbH), the lyophilized extract from eight bacterial species frequently responsible for upper respiratory tract infections, has been shown in several double-blind, controlled clinical trials to reduce incidence among both children and adults. The double-blind, randomized, placebo-controlled, multicenter study included 220 children (mean age 5.2 years) with a history of recurrent upper respiratory tract infections (URTIs), who presented with an acute URTI at enrollment visit. They were randomized and treated for five months. Patients in the OM-85 treatment group had an average of 2.1 URTIs over the five month treatment period, versus 2.5 in the placebo group (p<0.05), with the most pronounced effect seen in months 4, 5 (treatment) and 6 (observation). Dr. Schaad said the benefit of fewer URTIs was most pronounced for the children who had a history of more frequent URTIs Patients given OM-85 took significantly fewer local anti-infectious agents over the treatment period (5.22 percent versus 9.05 percent, p<0.05). Furthermore, the percentage of patients with worsening conditions during the study, by investigator and patient opinion, was 0.9 percent for OM-85 treatment versus 6.4 percent for placebo. Mild to severe rhinitis was seen in 37 percent of OM-85 treated patients, versus 43 percent of placebo treated patients, a finding that approached statistical significance. There was no significant difference between treatment and placebo in the number of patients reporting adverse events, which were mostly skin rashes and gastrointestinal problems. There is considerable interest in Switzerland in finding appropriate treatments for upper respiratory tract infections, which represent more than half of all pediatric consultations in that country, according to Dr. Schaad. Those infections are associated with considerable morbidity for children under five years of age, who are more likely than adults to have infections lasting longer than 14 days. About 16 percent of cases are complicated by secondary bacterial infections, acute otitis media, purulent sinusitis and bronchitis.
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