RESUMO
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).