Clinical and Immunological Benefits of OM-85 Bacterial Lysate in Patients with Allergic Rhinitis, Asthma, and COPD and Recurrent Respiratory Infections.
The aim of this study was to evaluate the efficacy of OM-85 in reducing the incidence of respiratory tract infections (RTIs) in patients with allergic rhinitis, asthma, or chronic obstructive pulmonary disease (COPD), and its effect on immunological parameters, namely serum and secretory IgA levels.



This was an open-label, prospective, sequential study which included 84 consecutive patients aged 16-65 years, who presented with recurrent (three or more) respiratory infections during the year prior to study entry. In the first year of the study, patients received standard optimized care (SOC), according to their underlying disease condition (asthma, allergic rhinitis, or COPD). In the following year, patients received treatment with OM-85 oral bacterial lysate (one 7 mg capsule daily for ten consecutive days per month, for 3 months), with a 6-month follow-up. Medical history, clinical symptoms, serum, and secretory IgA levels, and the number of infections and exacerbations were evaluated before and after treatment.



There was a decrease in the total number of RTIs before the OM-85 treatment period (SOC only) compared to the year before the study start [69/266 (corresponding to a 74 % reduction)] and an additional decrease [38/69 (corresponding to a 45 % reduction)] after OM-85 treatment; p < 0.05. There was also a significant reduction in the total number of exacerbations related to the patients' underlying medical conditions, which decreased from 55 to 35 during OM-85 (+SOC) treatment, corresponding to a reduction of 36 %. In addition, an increase in serum and secretory IgA levels which coincided with the administration of OM-85 was observed.



Our results showed the clinical benefits of OM-85 in reducing RTIs and exacerbations of the underlying medical condition, in patients with allergic rhinitis, asthma, or COPD.
Faculty of Medicine, University of Buenos Aires, Av. Medrano 367 - PB - Dto B - CABA, 1178, Buenos Aires, Argentina. akoatz@gmail.com.
Ana M
AM
Koatz
Hospital Aleman Buenos Aires, Buenos Aires, Argentina.
Noemí A
NA
Coe
Universidad Favaloro, Buenos Aires, Argentina.
Alberto
A
Cicerán
Hospital de Oncología María Curie, Buenos Aires, Argentina.
Adriana J
AJ
Alter
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D002457:Cell Extracts / Q000276:immunology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D065631:Rhinitis, Allergic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D012463:Saliva / Q000378:metabolism; D055502:Secondary Prevention / Q000379:methods; D012720:Severity of Illness Index; D000067251:Symptom Flare Up; D055815:Young Adult; D000095983:Bacterial Lysates
D000276:Adjuvants, Immunologic; D002457:Cell Extracts; D007070:Immunoglobulin A; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates
Asthma; Bacterial lysate; COPD; Exacerbation; OM-85; Re-infection; Respiratory tract infection; Rhinitis