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

Stefano Carlone; Michele Minenna; Peride Morlino; Luigi Mosca; Franco Pasqua; Riccardo Pela; Pietro Schino; Alberto Tubaldi; Emmanuele Tupputi; Fernando De Benedetto; and the Buccalin Trial Group

doi:10.4081/mrm.2014.393

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

Authors

Stefano Carlone Pulmonary Department of San Giovanni-Addolorata General Hospital, Respiratory Diseases I, Rome
Michele Minenna Civile di Bitonto Hospital, Pneumology, Bitonto (BA)
Peride Morlino Respiratory Diseases and Respiratory Rehabilitation, Teresa Masselli Mascia Hospital, San Severo (FG)
Luigi Mosca Pneumology and Respiratory Physiopathology Department, Hospital of Pescara, Pescara
Franco Pasqua Pneumology Rehabilitation, Villa delle Querce Hospital, Nemi, Rome, Italy
Riccardo Pela Pneumology Unit, C. e G. Mazzoni Hospital, Ascoli Piceno
Pietro Schino Department of Pulmonary Disease, F. Miulli Hospital, Acquaviva delle Fonti (BA)
Alberto Tubaldi Pneumology Department, General Hospital of Macerata, Macerata
Emmanuele Tupputi Local Health Unit, Hospital District 2, BAT, Andria (BT)
Fernando De Benedetto 0Pneumology Department, SS Annunziata Hospital, Chieti
and the Buccalin Trial Group The Buccalin® Trial Group

DOI: https://doi.org/10.4081/mrm.2014.393

Keywords:

Bacterial lysates, Immune-stimulation, Placebo-controlled trial, Recurrent respiratory infections

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.

Conclusion: The administration of 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.