EVALUATION OF THE EFFICACY OF PIDOTIMOD IN THE EXACERBATIONS IN PATIENTS AFFECTED WITH CHRONIC-BRONCHITIS

The efficacy and safety of pidotimod 2-pyrrolidinyl)carbonyl]-thiazoli dine-4-carboxylic acid, PGT/1A, CAS 121808-62-6), a new oral synthetic immunostimulating agent, were investigated in a multicentre study, pe rformed in 10 university and hospital centres of pneumophthisiology an d respiratory physiopathology, according to a double-blind vs. placebo experimental design. Primary objective of the investigation was to ve rify the efficacy of pidotimod against infectious exacerbations in pat ients affected with chronic bronchitis. 181 inpatients or outpatients (117 male, 64 female; mean age: 62.5 years), affected with chronic bro nchitis, were enrolled in the study. Pidotimod 800 mg/die or placebo s achets were administered by oral route for 60 consecutive days, follow ed by a 60-day follow-up period. Clinical observations were performed at baseline (D 0), after 30 (D 30) and 60 D 60) days of treatment, as well as at the end of the follow-up (D 120). Time and frequency of inf ectious relapses were considered as the target variable for the evalua tion of the efficacy of the drug. Clinical picture, expectoration char acteristics, spirometric parameters and laboratory tests were monitore d to evaluate patients' conditions. The results indicate that pidotimo d is significantly more effective than placebo against infectious rela pses in patients suffering from chronic bronchitis. During the first m onth, 9% of patients treated with pidotimod were affected with an infe ctious relapses vs. 39.5% of patients treated with placebo (chi(2), p < 0.001). In the second month, infectious episodes were reported by 1. 2% of patients treated with the drug vs. 46.1% of patients treated wit h placebo (chi(2), p < 0.001). During the follow-up, no respiratory in fectious episodes were observed in patients treated with pidotimod vs. 50% of patients treated with placebo (chi(2), p < 0.001). The drug wa s well tolerated and no significant changes of laboratory parameters w ere observed.