ABSTRACT
Aims: To identify the effect of the oral bacterial extract OM-85 on essential parameters of asthma control. Study Design: This was a double blind, prospective study, consistent of a 4 week run-in and a 24 week double blind period. Place and Duration of Study: An outpatient clinic, in collaboration with “St Andrew’s’’ General State Hospital in Patras/Greece, between October 2010 and April 2011. Methods: Patients (aged 15-57, N=130) with persistent allergic asthma, were assessed and divided accordingly, in three strata: Stratum I (not controlled asthma, NCA), stratum 2 (partly controlled asthma, PCA) and stratum 3 (controlled asthma, CA). At the end of the run-in period were randomized to receive additionally to their standard treatment (appropriate doses inhaled budesonide and formoterol), 7mg oral OM-85 BV or matching placebo. Primary end-point was the proportion of patients with controlled asthma in every group. Change from baseline budesonide, mean FEV1, PEF, daytime asthma symptoms score, night awakenings, rescue b2-agonist use and serum interferon-γ (INF-γ) levels were also recorded and included in the final analysis. Results: At the end of the 24 week follow up, stratum I patients, treated additionally with OM-85 BV, presented significantly higher proportion of subjects with controlled (28.09% versus 18.7%, P<0.001), and partly controlled asthma (57% versus 43.7%, (P= 0.04). Almost all patients demonstrated significant increases (P<0.001) from baseline in FEV1.The percentage change from baseline FEV1 was 21.8% for OM-85 BV versus 12.1% for the placebo group. Same tendencies were recorded in every stratum and concerned al secondary end points, despite a lower dose of budesonide. Conclusions: Patients treated additionally with OM-85 BV achieved better asthma control despite a lower dose of budesonide.