[Preventive effect of an immunomodulator, OM-85 BV, on acute exacerbations of chronic bronchitis in elderly patients. Preliminary results at six months in 291 patients]. / Effet préventif d'un immunomodulateur, l'OM-85 BV, sur les exacerbations aiguës de bronchite chronique du sujet âgé. Résultats préliminaires à 6 mois chez 291 patients.

ABSTRACT

Three hundred fifty six patients aged 65 years or more (mean age 81.8 years) who were suffering from chronic bronchitis were included in a double-blind trial against placebo to assess the preventative effect of OM-85 BV against acute exacerbations of chronic bronchitis. OM-85 BV is an immunostimulant composed of lyophilised factions of 8 bacteria which are most frequently encountered during the course of respiratory tract infections. 291 patients completed the study. In the group treated by OM-85 BV, a significant increase in the number of patients with no episode of acute bronchitis was noted (96 versus 71, p = 0.006). There was a 38.8% reduction in the absolute numbers of episodes of acute bronchitis and a 33% reduction in the number of prescriptions for antibiotics, however there was no difference in the number of pneumonias and bronchopneumonias. These results show the protective effect of OM-85 BV against bronchial superinfections in a large population of elderly patients suffering from chronic bronchitis.