Table 2 Description of clinical trials performed in the adult population

Cvoriscec B et al. 1989 [24]

52 OM-85 BV vs 52 placebo

20-69

Chronic brobnchitis

1 capsule/day for 1 mo; 1 capsule/10 days for mos 3, 4 and 5

6 mos including administration period

Decrease of duration of acute episodes and of fever (p<0.001); decrease of antibiotic consumption (p<0.05); increase of T lymphocyte count until 3rd mo after exacerbation (p<0.05); increased serum IgA levels (p<0.05)

Orcel B et al. 1994 [36]

147 OM-85 BV vs 143 placebo

>65

Chronic bronchitis

1 capsule 10 days/mo for 3 mo

6 mos including administration period

28% reduction of lower RTIs entirely due to 40% reduction in the number of episodes of bronchitis (p<0.01)

Collet JP et al. 1997 [37]

191 OM-85 BV vs 190 placebo

OM-85 BV: 65.3±7.7 Placebo: 66.9±7.7

COPD

1 capsule 10 days/mo for 3 mo

6 mos including administration period

No effect in occurrence of acute exacerbation; reduction in number of hospital admissions; decrease in duration of hospitalisation (p=0.037)

Li et al. 2004 [38]

49 OM-85 BV vs 41 placebo

55-82

Chronic bronchitis and COPD

1 capsule 10 days/mo for 3 mo

12 mos including administration period

Decrease in incidence, duration, and severity of acute exacerbation (p<0.01); decrease in consumption of antibiotics

Solér et al. 2007 [39]

142 OM-85 BV vs 131 placebo

22-78

Chronic bronchitis/ mild COPD

1 capsule/day for 1 mo; 1 capsule/10 days for mos 3, 4 and 5

6 mos including administration period

Decrease of acute exacerbations at the end of study (p=0.014). Difference between treatments higher in patients with current or past smoking history

Capetti et al. 2010 [42]

130 OM-85 BV

Not reported

HIV infection- high risk of RTI

1 capsule 10 days/mo for 3 mo

12 mos-comparison performed between year w/o and with treatment

Decrease of antibiotic cycles from 297 to 55. Decrease of hospitalisation from 23 to 6.

Tang et al. 2012 [40]

192 OM-85 BV vs 192 placebo

Not reported

Chronic bronchitis or COPD

1 capsule 10 days/mo for 3 mo

10 wks

Decrease in occurrence of exacerbation (p<0.05); decrease in antibiotic consumption (p<0.05)