Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children—The EOLIA study

Pediatric Allergy and Immunology

Volumn 29, Issue 4, 2018, Pages 394-401

  Emeryk, Andrzej ^a   Bartkowiak Emeryk, Malgorzata ^b   Raus, Zbigniew ^c   Braido, Fulvio ^d   Ferlazzo, Guido ^e   Melioli, Giovanni ^d  

^a Childrens University Hospital of Lublin   (Poland)

^b MEDICAL UNIVERSITY OF LUBLIN   (Poland)

^c LaserMed Diagnosis and Treatment Centre   (Poland)

^d UNIVERSITY OF GENOA   (Italy)

^e UNIVERSITY OF MESSINA   (Italy)

Author keywords

allergic asthma; children; exacerbation; PMBL Tablet

Indexed keywords

BACTERIUM LYSATE; ISMIGEN; PLACEBO; POLYVALENT MECHANICAL BACTERIAL LYSATE; UNCLASSIFIED DRUG; BRONCHO-VAXOM; CELL EXTRACT; IMMUNOLOGICAL ADJUVANT;

ADD ON THERAPY; ADOLESCENT; ALLERGIC ASTHMA; ARTICLE; CHILD; CLINICAL OUTCOME; CONTROLLED STUDY; DISEASE CONTROL; DISEASE COURSE; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HAEMOPHILUS INFLUENZAE TYPE B; HUMAN; KLEBSIELLA OZAENAE; KLEBSIELLA PNEUMONIAE; MAJOR CLINICAL STUDY; MALE; MORAXELLA CATARRHALIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS ORALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; TABLET; ASTHMA; FOLLOW UP; IMMUNOLOGY; ORAL DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, ORAL; ADOLESCENT; ASTHMA; CELL EXTRACTS; CHILD; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; TREATMENT OUTCOME;

EID: 85047844810     PISSN: 09056157     EISSN: 13993038     Source Type: Journal    
DOI: 10.1111/pai.12894     Document Type: Article

References (32)

1. Jackson DJ, Sykes A, Mallia P. Asthma exacerbations: origin, effect, and prevention. J Allergy Clin Immunol. 2011;128:1165-1174.
2. Brozek G, Lawson J, Shpakou A, et al. Childhood asthma prevalence and risk factors in three Eastern European countries–the Belarus, Ukraine, Poland Asthma Study (BUPAS): an international prevalence study. BMC Pulm Med. 2016;16:11.
3. Bahadori K, Doyle-Waters MM, Marra C, et al. Economic burden of asthma: a systematic review. BMC Pulm Med. 2009;9:24.
4. Covar RA, Szefler SJ, Zeiger RS, et al. Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children. J Allergy Clin Immunol. 2008;122:741-747.e4.
5. Ivanova JI, Bergman R, Birnbaum HG, Colice GL, Silverman RA, McLaurin K. Effect of asthma exacerbations on health care costs among asthmatic patients with moderate and severe persistent asthma. J Allergy Clin Immunol. 2012;129:1229-1235.
6. Singh AM, Busse W. Asthma exacerbation. 2: aetiology. Thorax. 2006;61:809-816.
7. Busse WW, Lemanske RF Jr, Gern JE. Role of viral respiratory infections in asthma and asthma exacerbations. Lancet. 2010;376:826-834.
8. Guilbert TW, Denlinger LC. Role of infection in the development and exacerbation of asthma. Expert Rev Respir Med. 2010;4:71-83.
9. Rosenthal LA, Avila PC, Heymann PW, et al. Viral respiratory tract infections and asthma: the course ahead. J Allergy Clin Immunol. 2010;125:1212-1217.
10. Gavala ML, Bashir H, Gern JE. Virus/allergen interactions in asthma. Curr Allergy Asthma Rep. 2013;13:298-307.
11. Murray CS, Poletti G, Kebadze T, et al. Study of modifiable risk factors for asthma exacerbations: virus infection and allergen exposure increase the risk of asthma hospital admissions in children. Thorax. 2006;61:376-382.
12. Global Initiative for Asthma ‐ GINA. http://ginasthma.org/. Accessed 2014
13. Cazzola M, Anapurapu S, Page CP. Polyvalent mechanical bacterial lysate for the prevention of recurrent respiratory infections: a meta-analysis. Pulm Pharmacol Ther. 2012;25:62-68.
14. Ricci R, Palmero C, Bazurro G, et al. The administration of a polyvalent mechanical bacterial lysate in elderly patients with COPD results in serological signs of an efficient immune response associated with a reduced number of acute episodes. Pulm Pharmacol Ther. 2014;27:109-113.
15. Gern JE. Virus/allergen interaction in asthma exacerbation. Ann Am Thorac Soc. 2015;12:S137-S143.
16. Banche G, Allizond V, Mandras N, et al. Improvement of clinical response in allergic rhinitis patients treated with an oral immunostimulating bacterial lysate: In vivo immunological effects. Int J Immunopathol Pharmacol. 2007;20:129-138.
17. Razi CH, Harmanci K, Abaci A, et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010;126:763-769.
18. Lu Y, Li Y, Xu L, Xia M, Cao L. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology. 2015;95:139-144.
19. Evans SE, Xu Y, Tuvim MJ, Dickey BF. Inducible innate resistance of lung epithelium to infection. Annu Rev Physiol. 2010;72:413-435.
20. Reddel HK, Taylor DR, Bateman ED, et al. An official american thoracic society/european respiratory society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180:59-99.
21. Loymans RJ, Ter Riet G, Sterk PJ. Definitions of asthma exacerbations. Curr Opin Allergy Clin Immunol. 2011;11:181-186.
22. Schatz M, Sorkness CA, Li JT, et al. Asthma control test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006;117:549-556.
23. Castro M. Placebo versus best-available-therapy control group in clinical trials for pharmacologic therapies: which is better? Proc Am Thorac Soc. 2007;4:570-573.
24. Brand PLP, Mäkelä MJ, Szefler SJ, Frischer T, Price D. Monitoring asthma in childhood: symptoms, exacerbations and quality of life. Eur Respir Rev. 2015;24:187-193.
25. Dougherty RH, Fahy JV. Acute exacerbations of asthma: epidemiology, biology and the exacerbation-prone phenotype. Clin Exp Allergy. 2009;39:193-202.
26. Kloepfer KM, Gern JE. Virus/allergen interactions and exacerbations of asthma. Immunol Allergy Clin North Am. 2010;30:553-563.
27. McClure R, Massari P, Satoskar A. TLR-dependent human mucosal epithelial cell responses to microbial pathogens. Front Immunol. 2014;5:386.
28. Evans SE, Scott BL, Clement CG, et al. Stimulated innate resistance of lung epithelium protects mice broadly against bacteria and fungi. Am J Respir Cell Mol Biol. 2010;42:40-50.
29. Duggan JM, You D, Cleaver JO, et al. Synergistic interactions of TLR2/6 and TLR9 induce a high level of resistance to lung infection in mice. J Immunol. 2011;186:5916-5926.
30. Spits H, Artis D, Colonna M, et al. Innate lymphoid cells — a proposal for uniform nomenclature. Nat Rev Immunol. 2013;13:145-149.
31. Eberl G, Colonna M, Di Santo JP, McKenzie ANJ. Innate lymphoid cells: a new paradigm in immunology. Science. 2015;348:aaa6566.
32. Karaca NE, Gulez N, Aksu G, Azarsiz E, Kutukculer N. Does OM-85 BV prophylaxis trigger autoimmunity in IgA deficient children? Int Immunopharmacol. 2011;11:1747-1751.