TY - JOUR
T1 - The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract
T2 - The results of a double blind, placebo controlled, multicenter clinical trial
AU - Braido, Fulvio
AU - Melioli, Giovanni
AU - Candoli, Piero
AU - Cavalot, Andrea
AU - Di Gioacchino, Mario
AU - Ferrero, Vittorio
AU - Incorvaia, Cristoforo
AU - Mereu, Carlo
AU - Ridolo, Erminia
AU - Rolla, Giovanni
AU - Rossi, Oliviero
AU - Savi, Eleonora
AU - Tubino, Libero
AU - Reggiardo, Giorgio
AU - Baiardini, Ilaria
AU - di Marco, Eddi
AU - Rinaldi, Gilberto
AU - Canonica, Giorgio Walter
AU - Accorsi, Carlo
AU - Bossilino, Claudia
AU - Bonzano, Laura
AU - DiLizia, Michela
AU - Fedrighini, Barbara
AU - Garelli, Valentina
AU - Gerace, Vincenzo
AU - Maniscalco, Sara
AU - Massaro, Ilaria
AU - Messi, Alessandro
AU - Milanese, Manlio
AU - Peveri, Silvia
AU - Penno, Arminio
AU - Pizzimenti, Stefano
AU - Pozzo, Tiziana
AU - Raie, Alberto
AU - Regina, Sergio
AU - Sclifò, Francesca
PY - 2014/12/1
Y1 - 2014/12/1
N2 - Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.
AB - Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.
KW - Allergy
KW - Bacterial lysates
KW - Immune-stimulant drugs
KW - Prophylactic treatment
KW - Recurrent respiratory tract infections
UR - http://www.scopus.com/inward/record.url?scp=84912562005&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84912562005&partnerID=8YFLogxK
U2 - 10.1016/j.imlet.2014.10.026
DO - 10.1016/j.imlet.2014.10.026
M3 - Article
AN - SCOPUS:84912562005
SN - 0165-2478
VL - 162
SP - 185
EP - 193
JO - Immunology Letters
JF - Immunology Letters
IS - 2
ER -