Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children—The EOLIA study. Issue 4 (June 2018)

• Record Type: Journal Article
• Authors: Emeryk, Andrzej; Bartkowiak‐Emeryk, Malgorzata; Raus, Zbigniew; Braido, Fulvio; Ferlazzo, Guido; Melioli, Giovanni
• Is Part Of: Pediatric allergy and immunology. Volume 29:Issue 4(2018)
• Page Start: 394
• Page End: 401
• Publication Date: 2018-06
• Subjects: allergic asthma -- children -- exacerbation -- PMBL® Tablet; Allergy in children -- Periodicals; Immunologic diseases in children -- Periodicals; 617
• DOI: 10.1111/pai.12894
• Languages: English
• ISSNs: 0905-6157

Abstract

Abstract: Background: Despite progress in asthma management, prevention of asthma exacerbation remains challenging in school‐aged children with allergic asthma. New therapeutic approaches are needed. Previously, a chemical bacterial lysate has been successfully used in preschool children to reduce wheezing attacks. We assessed the effect of Polyvalent Mechanical Bacterial Lysate (PMBL ® ) Tablet on asthma clinical course and control in 6‐ to 16‐year‐old children with partly controlled or uncontrolled allergic asthma. Methods: A randomized, double‐blind, placebo‐controlled, parallel‐group study was performed in 152 patients exhibiting allergic asthma assigned to receive Placebo or PMBL ® . Eligible patients underwent four visits during the 9‐month study. Asthma control level was assessed by ACT/C‐ACT score. Results: The main criterion was not achieved as ACT/C‐ACT changes were similar in both groups at the end of the 3‐month treatment period. However, the mean number (±SD) of asthma exacerbations was significantly lower with PMBL ® Tablet than with Placebo at Week 12 (0.3 ± 0.6 vs 0.8 ± 1.1, P = .009) and over the total study period (1.1 ± 1.3 vs 1.9 ± 2.0, P = .01). Consistently, the mean number of days with exacerbation per patient was significantly lower with PMBL ® Tablet (13.3 ± 11.2 vs 19.8 ± 15.7 over the whole study, P = .009). Treatment with PMBL ® Tablet prolonged the time to second exacerbation by 55% (Hazard Ratio [HR]=0.45; 95% Confidence Interval [CI] 0.27 to 0.77, P = .002) and to third exacerbation by 74% (HR=0.26; 95% CI 0.12 to 0.58, P < .001). No serious adverse event related to PMBL ® Tablet administration was recorded. Conclusion: Administration of PMBL ® Tablet represents a safe and effective means for significantly reducing the rate of exacerbations in school‐aged allergic asthmatic children. (EudraCT 2013‐000737‐12 and NCT02541331)