title: Efficacy and Safety of OM-85 in Patients with Chronic Bronchitis and/or Chronic Obstructive Pulmonary Disease.
abstract: BACKGROUND
  Recurrent acute exacerbations are generally associated with accelerated decline of lung function and characterized by reduced physical activity and worsening of clinical status in patients with chronic obstructive pulmonary disease (COPD). Effective practices and therapies aimed at preventing acute exacerbations are continuously under investigation by healthcare providers. This double-blind, placebo-control, randomized clinical trial sought to evaluate the preventive effect of a bacterial lysate (OM-85) on acute exacerbations in patients with COPD or chronic bronchitis in China.
  
  
  METHODS
  A total of 428 patients were randomly assigned either to OM-85 treatment or to placebo. Patients received study drug or placebo for 10 days per month over 3 consecutive months, with a 10-week follow-up. Three hundred and eighty-four (384) patients completed the study (192 in the OM-85 group and 192 in the placebo group) and were included in the full analysis set (FAS). Thirty (30) patients, 21 in the OM-85 and 9 in the placebo groups, were excluded due to protocol violations and drop-outs, and the remaining 354 patients (171 in the OM-85 and 183 in the placebo groups) were included in the per protocol set (PPS).
  
  
  RESULTS
  The proportion of patients with recurrent acute exacerbations in the OM-85 group was significantly lower than in the placebo group at the end of the treatment period, both, in the FAS (23.4 % vs. 33.3 %, p = 0.0311) and in the PPS (17.0 % vs. 31.2 %, p < 0.05). Throughout the entire 22-week study period, the proportion of patients with recurrent acute exacerbations in the OM-85 group was lower than in the placebo group in the FAS (32.8 % vs. 38.0 %, p = 0.277), while the difference is statistically significant in the PPS (26.3 % vs. 36.1 %, p < 0.05).
  
  
  CONCLUSIONS
  OM-85 significantly reduced the proportion of patients with acute exacerbation after 12 weeks of therapy and the benefit appeared to be maintained up to 22 weeks, and showed a favorable tolerability profile.
authors.affiliation: Department of Respiratory Medicine, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Tang
authors.forename: Zheng
authors.initials: Z
authors.lastname: Fang
authors.forename: Gabriela P
authors.initials: GP
authors.lastname: Saborío
authors.forename: Qingyu
authors.initials: Q
authors.lastname: Xiu
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D029481:Bronchitis, Chronic / Q000150:complications / Q000188:drug therapy*; D002457:Cell Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D003371:Cough / Q000209:etiology; D018450:Disease Progression; D004311:Double-Blind Method; D004417:Dyspnea / Q000209:etiology; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D013183:Sputum; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D002457:Cell Extracts; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates