Background: This study investigated the value of adding Ismigen, a polyvalent mechanical bacterial lysate, to therapy of COPD patients (FEV(1) <60% predicted) under regular treatment with salmeterol/fluticasone (SFC).
Methods: 63 patients enrolled from September to December 2007 were randomly divided into two groups (A and B). All patients were treated with salmeterol/fluticasone (SFC) 50/500 microg BID. Thirty-three subjects also received Ismigen one capsule daily the first 10 days of three consecutive months (group B). This treatment was reaped three months after the end of the first course. We assessed at inclusion and at scheduled (every 2 months) or intercurrent visit: symptoms (amount and colour of sputum, severity of dyspnoea, frequency of cough, fever), diagnosis of exacerbation, concomitant medications (antibiotics and oral corticosteroids) and hospitalization.
Results: During the course of the study two patients died. At the end of the observation period (12 months), another six patients could not be visited because they had withdrawn. Compared with SFC, adding on Ismigen reduced the total number of exacerbations (23 out of 30 patients in group A and 21 out of 33 patients in group B), the number (rate) of exacerbations per patient per year (18 out of 27 patients [0.67] in group A and 15 out of 28 patients [0.54] in group B), the number of exacerbations that needed treatment with oral corticosteroids (12 out of 23 [52%] in group A and 9 out of 21 [43%] in group B) and the total number (rate) of hospitalizations (4/30 [0.13] in group A and 3/33 [0.09] in group B). There were no significant differences between treatments with respect to their effect on the symptoms of exacerbations. A decrease in the need for antibiotics was also observed in group B.
Conclusion: Our data suggest that COPD patients benefit from the addition of Ismigen on top of the routine maintenance treatment with SFC.