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Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children-The EOLIA study
Andrzej Emeryk1, Malgorzata Bartkowiak-Emeryk2, Zbigniew Raus3
1Department of Paediatric Pulmonology and Rheumatology, University Children Hospital of Lublin, Lublin, Poland.
Insights
Polyvalent Mechanical Bacterial Lysate (PMBL) tablets significantly reduced asthma exacerbations in allergic children. This safe treatment offers a new approach for managing asthma in school-aged children.
Area of Science:
- Pediatric Allergy and Immunology
- Respiratory Medicine
- Pharmacology
Background:
- Asthma exacerbations remain a challenge in school-aged children with allergic asthma.
- New therapeutic strategies are needed for effective asthma management.
- Previous studies indicated bacterial lysates can reduce wheezing in younger children.
Purpose of the Study:
- To evaluate the efficacy of Polyvalent Mechanical Bacterial Lysate (PMBL) tablets in managing allergic asthma in children aged 6-16.
- To assess the impact of PMBL on asthma control and exacerbation rates.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 152 children with allergic asthma.
- Participants received either PMBL tablets or a placebo over a 9-month period.
- Asthma control was assessed using the Asthma Control Test (ACT/C-ACT) score.
Main Results:
- While the primary endpoint (ACT/C-ACT changes) was not met, PMBL significantly reduced the number of asthma exacerbations at 12 weeks and throughout the study.
- Patients on PMBL experienced fewer exacerbation days and a prolonged time to subsequent exacerbations.
- No serious adverse events were associated with PMBL administration.
Conclusions:
- PMBL tablets are a safe and effective option for reducing asthma exacerbations in school-aged children with allergic asthma.
- This treatment shows promise in improving the clinical course of allergic asthma in pediatric populations.
- Further research may explore long-term effects and broader applications of PMBL.
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).
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