title: The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: the results of a double blind, placebo controlled, multicenter clinical trial.
abstract: 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.
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Braido
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy. Electronic address: giovannimelioli@gmail.com.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Melioli
authors.affiliation: Divisione Pneumologica, Ospedale Lugo di Romagna Viale Dante, 10, 48022 Lugo, RA, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Candoli
authors.affiliation: Ospedale S. Croce Moncalieri (TO), P.zza A. Ferdinando, 3, 10024 Moncalieri, TO, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cavalot
authors.affiliation: Dipartimento di Medicina e Scienza dell'Invecchiamento, Immunologia e medicina del lavoro, Università G. D'Annunzio, Chieti Via dei Vestini, 31, 66100 Chieti, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Di Gioacchino
authors.affiliation: Ospedale Gradenigo Torino, C.so Regina Margherita, 8, 10153 Torino, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ferrero
authors.affiliation: Istituti Clinici di perfezionamento, Milano Via Bignami, 1, 20126 Milano, Italy.
authors.forename: Cristoforo
authors.initials: C
authors.lastname: Incorvaia
authors.affiliation: Centro Asma, Struttura Complessa Pneumologia, Ospedale Santa Corona, Via XXV Aprile, 38, Pietra Ligure, SV, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Mereu
authors.affiliation: Ambulatorio di Allergologia Padiglione Barbieri 2° piano, Dipartimento di Scienze Cliniche, Università degli Studi di Parma, Via Gramsci, 14, 43125 Parma, Italy.
authors.forename: Erminia
authors.initials: E
authors.lastname: Ridolo
authors.affiliation: Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche dell'Università di Torino & AO Ordine Mauriziano, Largo Turati, 62, 10128 Torino, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rolla
authors.affiliation: Azienda Ospedaliera Universitaria Careggi, D.A.I. Biomedicina - S.O.D. Immunoallergia PAD, 13, Largo Brambilla 3, Firenze, Italy.
authors.forename: Oliviero
authors.initials: O
authors.lastname: Rossi
authors.affiliation: UO di Allergologia, AUSL di Piacenza, Via Taverna, 49, 29100 Piacenza, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Savi
authors.affiliation: Ospedale di Chivasso (TO), C.so Galileo Ferraris, 3, 10034 Chivasso, Italy.
authors.forename: Libero
authors.initials: L
authors.lastname: Tubino
authors.affiliation: Biometry unit, Mediservice srl, Milano, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Reggiardo
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Baiardini
authors.affiliation: Laboratorio di Analisi, Istituto G. Gaslini, Via G. Gaslini 5, 16147 Genova, Italy.
authors.forename: Eddi
authors.initials: E
authors.lastname: di Marco
authors.affiliation: Direzione Medica, Bruschettini srl, Via Isonzo 5, 16147 Genova, Italy.
authors.forename: Gilberto
authors.initials: G
authors.lastname: Rinaldi
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
authors.forename: Giorgio Walter
authors.initials: GW
authors.lastname: Canonica
authors.affiliation: Ospedale S. Croce Moncalieri (TO), P.zza A. Ferdinando, 3, 10024 Moncalieri, TO, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Accorsi
authors.affiliation: Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche dell'Università di Torino & AO Ordine Mauriziano, Largo Turati, 62, 10128 Torino, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Bossilino
authors.affiliation: Ambulatorio di Allergologia Padiglione Barbieri 2° piano, Dipartimento di Scienze Cliniche, Università degli Studi di Parma, Via Gramsci, 14, 43125 Parma, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Bonzano
authors.affiliation: Dipartimento di Medicina e Scienza dell'Invecchiamento, Immunologia e medicina del lavoro, Università G. D'Annunzio, Chieti Via dei Vestini, 31, 66100 Chieti, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: DiLizia
authors.affiliation: Ospedale S. Croce Moncalieri (TO), P.zza A. Ferdinando, 3, 10024 Moncalieri, TO, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Fedrighini
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Garelli
authors.affiliation: Ospedale di Chivasso (TO), C.so Galileo Ferraris, 3, 10034 Chivasso, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Gerace
authors.affiliation: Centro Asma, Struttura Complessa Pneumologia, Ospedale Santa Corona, Via XXV Aprile, 38, Pietra Ligure, SV, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Maniscalco
authors.affiliation: Azienda Ospedaliera Universitaria Careggi, D.A.I. Biomedicina - S.O.D. Immunoallergia PAD, 13, Largo Brambilla 3, Firenze, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Massaro
authors.affiliation: Divisione Pneumologica, Ospedale Lugo di Romagna Viale Dante, 10, 48022 Lugo, RA, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Messi
authors.affiliation: Centro Asma, Struttura Complessa Pneumologia, Ospedale Santa Corona, Via XXV Aprile, 38, Pietra Ligure, SV, Italy.
authors.forename: Manlio
authors.initials: M
authors.lastname: Milanese
authors.affiliation: UO di Allergologia, AUSL di Piacenza, Via Taverna, 49, 29100 Piacenza, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Peveri
authors.affiliation: Ospedale S. Croce Moncalieri (TO), P.zza A. Ferdinando, 3, 10024 Moncalieri, TO, Italy.
authors.forename: Arminio
authors.initials: A
authors.lastname: Penno
authors.affiliation: Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche dell'Università di Torino & AO Ordine Mauriziano, Largo Turati, 62, 10128 Torino, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Pizzimenti
authors.affiliation: Ospedale Gradenigo Torino, C.so Regina Margherita, 8, 10153 Torino, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Pozzo
authors.affiliation: Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche dell'Università di Torino & AO Ordine Mauriziano, Largo Turati, 62, 10128 Torino, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Raie
authors.affiliation: Ospedale Gradenigo Torino, C.so Regina Margherita, 8, 10153 Torino, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Regina
authors.affiliation: Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Sclifò
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D049690:History, Ancient; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D000942:Antigens, Bacterial
keywords: Allergy; Bacterial lysates; Immune-stimulant drugs; Prophylactic treatment; Recurrent respiratory tract infections