title: Clinical efficacy and tolerability of an immune-stimulant(*) constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study.
abstract: BACKGROUND
  (Buccalin ®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin ®) to reduce the number of days with infectious episodes in patients with RRTI.
  
  
  METHODS
  A double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months.
  
  
  RESULTS
  From a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded.
  
  
  CONCLUSIONS
  The administration of bacterial lysate (Buccalin ®) in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.
authors.affiliation: Pulmonary Department of San Giovanni-Addolorata General Hospital, Respiratory Diseases I, Via dell'Amba Aradan 9, Rome, 00184 Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Carlone
authors.affiliation: Pneumology, Civile di Bitonto Hospital, Via Gomes 32, Bitonto, BA 70032 Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Minenna
authors.affiliation: Respiratory Diseases and Respiratory Rehabilitation, Teresa Masselli Mascia Hospital, Via 2 Giugno, San Severo, FG 71016 Italy.
authors.forename: Paride
authors.initials: P
authors.lastname: Morlino
authors.affiliation: Pneumology and Respiratory Physiopathology Department, Hospital of Pescara, Via Fonte Romana 8, Pescara, 65124 Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Mosca
authors.affiliation: Pneumology Rehabilitation, Villa delle Querce Hospital, Nemi, Rome Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Pasqua
authors.affiliation: Pneumology Unit, C. e G. Mazzoni Hospital, Via degli Iris 1, Ascoli Piceno, 63100 Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Pela
authors.affiliation: Department of Pulmonary Disease, F. Miulli Hospital, Strada Prov. 127 Acquaviva - Santeramo Km. 4,100, Acquaviva delle Fonti, BA 70021 Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Schino
authors.affiliation: Pneumology Department, General Hospital of Macerata, Via Santa Lucia 2, Macerata, 62100 Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Tubaldi
authors.affiliation: Local Health Unit, Hospital District 2, BAT, Via Vittore Carpaccio, Andria, BT 70031 Italy.
authors.forename: Emmanuele
authors.initials: E
authors.lastname: Tupputi
authors.affiliation: Pneumology Department, SS Annunziata Hospital, Chieti, Italy.
authors.forename: Fernando
authors.initials: F
authors.lastname: De Benedetto
keywords: Bacterial lysates; Immune-stimulation; Placebo-controlled trial; Recurrent respiratory infections