Abstract
Objective: This study was a double-blind, placebo-controlled, randomized clinical trial to evaluate the preventive effect of bacterial lysates (Broncho-Vaxom, OM-85 BV) on acute exacerbation in patients with COPD or chronic bronchitis in China.
Methods: 428 patients recruited from 13 centers were randomly allocated into BV or placebo. 384 patients completed the study (192 in OM-85 BV group and 192 in the placebo group). Patients received medications for 10 days per month during 3 months with a 10-week follow-up.
Results: This study revealed that the proportion of patients with recurrent exacerbation in OM-85 BV group was significantly lower than that in placebo group within 12-week treatment period (23.4% vs. 33.3%, p<0.05). Among all subjects having exacerbation (≥1 time), the percentage of patients with recurrent exacerbations (≥2 times) was significantly lower in OM-85 BV group than that in placebo group during the 12-week treatment period (38.7% vs. 73.1%, p<0.01). The percentage of concomitant antibiotics was significantly lower in OM-85 BV group than that in placebo group (37.0% vs. 63.0%, p<0.05). In terms of safety, there was no significant difference between the two groups in the incidence of adverse events (27.9% in BV group vs. 27.7% in placebo group, p>0.05).
Conclusions: OM-85 BV significantly reduced the rate of recurrent exacerbations in patients with chronic bronchitis or COPD in therapy period. It also significantly reduced the frequency of exacerbations in individual patients in active therapy period and decreased the usage of antibiotics, with a good safety profile.
- © 2011 ERS