Immucytal® 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 (URTIs) are common in children and are associated with high morbidity high rates of medical consultations and hospitalization and a significant economic burden for society Immunotherapy has long been used to boost the immune system and to confer protection 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-controlled, double-blind study was to evaluate the efficacy and tolerability of an oral ribosomal immunostimulant (Immucytal® tablets), in children (n = 114) with recurrent URTIs. Immucytal® was administered according to the following schedule: 1 tablet per day for 4 days per week on 3 consecutive weeks (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 were considered: incidence of lower respiratory tract infections, fever, number of medical consultations and adjunct treatments required. At the end of the study the clinical score showed a significant reduction in patients treated with Immucytal® compared with placebo for all the items considered. Concomitantly, a significant rise of plasma immunoglobulin G (IgG), IgM and IgA, as well as secretory IgA levels was seen. No relevant changes in ventilatory 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®, a ribosomal immunostimulant, is safe and efficacious in children with recurrent URTIs.