Immucytal (R) in the prevention and treatment of recurrent upper respiratory tract infections in children: A randomized, placebo-controlled, double-blind study

Recurrent upper respiratory tract infections (URTls) are common in children and are associated wi;fh high morbidity high rates of medical consultation s and hospitalization and a significant economic burden for society Immunot herapy has long been used to boost the immune system and to confer protecti on against microbial infections. Ribosomal immunotherapy has been shown to stimulate both specific and nonspecific immune responses, particularly the mucosal immune defense system. The aim of this multicenter; placebo-control led, double-blind study was to evaluate the efficacy and tolerability of an oral ribosomal immunostimulant (Immucytal (R) tablets), in children (n = 1 14) with recurrent URTls. Immucytal (R) was administered according to the f ollowing schedule: ? tablet per day for 4 days per week on 3 consecutive we eks (first month), followed by 1 tablet per day for 4 days every month for the following 5 months. The main efficacy parameter was a semiquantitative evaluation of clinical efficacy by a clinical score, The following items we re considered: incidence of lower respiratory tract infections, fever numbe r of medical consultations and adjunct treatments required. At the end of t he study the clinical score showed a significant reduction in patients trea ted with, Immucytal (R) compared with placebo for ail the items considered. Concomitantly, a significant rise of plasma immunoglobulin G (IgG), IgM an d IgA, as well as secretory IgA levels was seen. No relevant changes in ven tilatory function measures were observed Seventy-one percent of physicians and 80% of the patients' parents judged the treatment good or very good. No serious drug-related adverse events occurred. These results show that the oral formulation of Immucytal (R) a ribosomal immunostimulant, is safe and efficacious in children with recurrent URTls.