title: Sub-lingual administration of a polyvalent mechanical bacterial lysate (PMBL) in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD spirometric classification: A multicentre, double-blind, randomised, controlled, phase IV study (AIACE study: Advanced Immunological Approach in COPD Exacerbation).
abstract: Polyvalent mechanical bacterial lysates (PMBLs) have been shown to reduce the number of infectious episodes in patients with recurrent infections of the respiratory tract. Some previous investigations have also shown the effectiveness of PMBLs in reducing exacerbations of chronic obstructive pulmonary disease (COPD). The AIACE study, which was developed according to criteria of evidence-based medicine, evaluated whether the administration of PMBLs to COPD patients, in addition to the recommended treatment, was able to reduce the number of exacerbations by 25%. Two hundred eighty-eight patients with moderate to very severe COPD were recruited and randomly assigned to either placebo or PMBLs. The placebo or PMBLs were administered according to the standard scheme. The primary outcome of the study was not achieved. However, the number of days with fever (21 days per year versus 40.15; p < 0.001), the days of hospitalisation (65 days vs 162 days; p < 0.001), the interval between the first and second exacerbations (123.89 days vs 70.36; p = 0.03) and the number of days in poor health (109 days/year vs 171 days/year; p < 0.001) were significantly better in the PMBL group than in the placebo group. In conclusion, the results of this trials showed that Ismigen, in addition to guideline-suggested treatment, could not significantly reduce the number of exacerbations in the considered population; nevertheless, the secondary outcome results demonstrated potential benefits of this compound for relevant clinical outcomes.
authors.affiliation: Clinica di Malattie Allergologiche e Respiratory, Padiglione Maragliano-A.O.U. San Martino, A.O.U. San Martino, Largo R. Benzi 10, 16132 Genova, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Braido
authors.affiliation: Clinica di Malattie Allergologiche e Respiratory, Padiglione Maragliano-A.O.U. San Martino, A.O.U. San Martino, Largo R. Benzi 10, 16132 Genova, Italy. Electronic address: giovannimelioli@gmail.com.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Melioli
authors.affiliation: Unità di Farmacologia Clinica Respiratoria, Dipartimento di Medicina Interna A.O. Universitaria Policlinico Tor Vergata di Roma, Viale Oxford, 81-00133 Roma, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Cazzola
authors.affiliation: Department of Respiratory Diseases, University of Modena, Modena, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Fabbri
authors.affiliation: Department of Pathophysiology and Transplantation, University of Milan, IRCCS Fondazione Cà Granda Milano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Blasi
authors.affiliation: IRCCS G. Gaslini, Genova, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Moretta
authors.affiliation: Clinica di Malattie Allergologiche e Respiratory, Padiglione Maragliano-A.O.U. San Martino, A.O.U. San Martino, Largo R. Benzi 10, 16132 Genova, Italy.
authors.forename: Giorgio Walter
authors.initials: GW
authors.lastname: Canonica
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D002457:Cell Extracts / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000453:epidemiology / Q000209:etiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D012720:Severity of Illness Index; D013147:Spirometry; D016896:Treatment Outcome; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D002457:Cell Extracts; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates
keywords: Bacterial lysate; Chronic obstructive pulmonary disease (COPD); Immune stimulation; Polyvalent mechanical bacterial lysate (PMBL)