Use of a polyvalent bacterial lysate in patients with recurrent respiratory tract infections: Results of a prospective, placebo-controlled, randomized, double-blind study

Respiratory tract infections (RTIs) are the most common infections in human s, and it is difficult to effectively treat patients with increased suscept ibility to these ailments. LW 50020 (Luivac(R); Paspat(R) oral), an oral im munomodulator consisting of the antigens of seven bacteria commonly involve d in RTIs, has been developed for the induction of specific and nonspecific immune responses of the mucosa-associated lymphoid tissue. In this placebo -controlled study, the efficacy and safety of the tablet formulation of LW 50020 were evaluated in children and adults with recurrent RTIs. Tablets we re taken once daily during two periods of 4 weeks each, interrupted by a tr eatment-free interval of 4 weeks. The main endpoint of the study, a clinica l severity score that evaluated treatment benefits, was significantly lower in the second study period in patients treated with the bacterial lysate c ompared to patients given placebo. A comparison of the infection rates in t he first and second study periods of patients treated with LW 50020 reveale d a placebo-corrected reduction of 39% in children and a placebo-corrected reduction of 44% in adolescents and adults. The placebo-corrected duration of infections was shortened by 47% in children and by 55% in older patients . No serious drug-related side effects occurred. This study demonstrated th at the oral bacterial immunomodulator LW 50020 is efficacious in treating p atients with recurrent RTIs.