IMMUNOACTIVATION BY PIDOTIMOD IN CHILDREN WITH RECURRENT RESPIRATORY-INFECTIONS

The therapeutic activity and safety of pidotimod 2-pyrrolidinyl)carbon yl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6), a new sy nthetic ''biological response modifier'', were examined in a double-bl ind, placebo-controlled, multicentre trail in 101 children, including 53 boys and 48 girls aged 2-13 years (mean +/- SD: 4.7 +/- 2.1 years) with a history of recurrent respiratory infections (RRI). Pidotimod (4 00 mg/day) or placebo were administered orally for 60-day follow-up pe riod. The trial was completed by 89.1% of patients. The results indica te that pidotimod has a beneficial effect in children with recurrent r espiratory infections: the percentage of patients presenting symptoms affecting the upper and lower airways was significantly lower after tr eatment with the active drug than after treatment with placebo. Releva nt side effects were not reported during the trial. An evaluation of t he expression of CD25 (after in vitro stimulation of circulating monon uclear cells with PHA) before and after treatment with the two product s revealed a significant increase in CD25+ cells in the group treated with pidotimod but not in the group treated with placebo.