Study reveals benefits of Ismigen in COPD treatment
A pilot clinical study has confirmed the potential of Ismigen in the management of chronic obstructive pulmonary disease (COPD).
A pilot clinical study has confirmed the potential of Ismigen in the management of chronic obstructive pulmonary disease (COPD).
Ismigen is a Polyvalent Mechanical Bacterial Lysate (PMBL) produced by Lallemand Pharma International at its GMP certified facility in France. It is recommended in the prophylaxis and treatment of chronic and acute respiratory infections and diseases.
The new clinical study investigated the value of adding Ismigen to therapy of COPD patients with FEV1 <60% predicted (forced expiratory volume in 1 second), under regular treatment with salmeterol/fluticasone. It was conducted over a nine-month period on 63 patients and confirmed previous findings.
The study found that the administration of Ismigen in addition to regular treatment reduced the rate of exacerbations for each patient per year by 20% (0.54 vs 0.67 in control group). The immunostimulant drug also reduced the number of exacerbations that needed treatment with oral corticosteroids, as well as the total number of hospitalisations and the need for antibiotics.
The study confirmed previous results obtained with Ismigen in COPD patients (Cogo et al. 2003), (Cazzola, 2006, double-blind placebo controlled trial involving 178 patients).
Mario Cazzola, associate professor of respiratory medicine at the University of Rome, who directed the present study, said: "The results suggest that Ismigen is effective in advanced COPD patients, those with severely impaired lung function and, consequently, at high risk, and its protective effect may be additive to the other treatments."
The researchers said the efficacy of Ismigen could be linked to its pharmacological properties, including the excellent antigenic properties of the bacterial lysates, due to the mechanical lysis process and the sub-lingual administration route, which avoids denaturing the antigens and puts them in direct contact with antigen presenting cells (immature dendritic cells).
The pilot clinical study was published in Therapeutic Advances in Respiratory Disease online.