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Abstract Background This study aims to assess the effectiveness of OM-85 BV in treating recurrent acute tonsillitis in children and adults during the first year after treatment, as well as to identify response predictors. Results The study included 92 patients, and there was a significant decrease in the number of acute tonsillitis cases after OM-85 BV treatment (p

Background: This study aims to assess the effectiveness of OM-85 BV in treating recurrent acute tonsillitis in children and adults during the first year after treatment, as well as to identify response predictors. Results: The study included 92 patients, and there was a significant decrease in the number of acute tonsillitis cases after OM-85 BV treatment (p < 0.001). Exposure to tobacco smoke predicts non-response or partial response to treatment (OR 5.24, p = 0.005, 95% CI 1.646–16.671/OR 4.57, p = 0.014, 95% CI 1.362–15.339). Conclusions: The study concludes that OM-85 BV is effective in preventing new episodes of tonsillitis in patients with a history of recurrent acute tonsillitis. Patients exposed to tobacco smoke tend to have a poorer response to treatment. [ABSTRACT FROM AUTHOR]

This study aimed to identify the effects of OM-85 BV in patients with chronic obstructive pulmonary disease (COPD). PubMed, Embase, CINAHL, and were searched for eligible randomized controlled trials (RCTs). The major end point was exacerbation rate, and the minor end points included duration of hospitalization, severity of acute exacerbation, incidence rate of patients using antibiotics, and adverse events. All data were derived with relative risks (RRs) and weighted mean differences. Five RCTs with 1190 patients were enrolled in the meta-analysis. OM-85 BV was associated with 20% and 39% reductions in exacerbation rate (RR, 0.80; 95% confidence interval [CIs], 0.65-0.97; P = .03) and incidence rate of patients using antibiotics (RR, 0.61; 95%CI, 0.48-0.77; P < .0001) compared with the placebo. However, OM-85 BV was not significantly associated with duration of hospitalization, severity of acute exacerbation, and total adverse events. Current evidence supporting the benefits of OM-85 BV to COPD patients is inadequate. Further larger-scale trials must be conducted to validate our findings and the efficacy of OM-85 BV in COPD patients. [ABSTRACT FROM AUTHOR]

Highlights: [•] The immunogenicity and efficacy of IIV are not completely satisfactory in children. [•] OM-85 BV does not seem to increase the humoral and cell-mediated immune response to IIV. [•] Combined OM-85 and IIV seems to reduce respiratory morbidity in children with RRTIs. [•] Combined OM-85 and IIV seems to be safe and well tolerated. [ABSTRACT FROM AUTHOR]

Background: According to the hygiene hypothesis, bacterial infections during early life contribute to a reduced incidence of asthma in animals. However, the effects of microbial products at a safe dose and within a rational time course on the prevention of allergic rhinitis (AR) have been inconclusive. This study investigated the immunomodulatory effects of oral administration of a bacterial extract, OM-85 Broncho-Vaxom (BV), with a low dose and general time course, which is currently used for respiratory infections in humans, on AR inflammation in mice. Methods: We developed a mouse model of ovalbumin (OVA)-induced AR allergic inflammation in the nose mucosa of mice. Low doses of OM-85 BV were orally administered for 3 months (long term) before sensitization. We evaluated nasal symptoms, pathology in the nose, inflammatory cells, and the levels of T helper 1 (Th1)/Th2 cytokines in the nasal lavage fluids, and the serum levels of specific IgE and IgG1. We also observed enhanced effects of OM-85BV with 1 month (short term) of treatment. Results: We found that long-term pretreatment with OM-85 BV protected the mice from the majority of allergy-specific symptoms; specifically, OM-85 BV suppressed nasal symptoms, inhibited eosinophil infiltration in the nose, inhibited inflammatory infiltrates and the Th2 response by reducing cytokines (IL-4, IL-5, or IL-13) in the nasal lavage fluids, and reduced IgE and IgG1 levels. Furthermore, short-term treatment with OM-85 BV decreased the levels of Th2 cytokines and IgE. Conclusion: Taken together, our data suggested that OM-85 BV is a low-cost alternative candidate to prevent AR with simple oral administration. [ABSTRACT FROM AUTHOR]

Background: No reagents have been shown to be effective in preventing wheezing attacks provoked by acute respiratory tract illnesses (ARTIs) in preschool children. New therapeutic agents and preventive strategies are needed. Objectives: We assessed the effect of OM-85 BV (Broncho-Vaxom; OM Pharma, Geneva, Switzerland) in preventing ARTI-provoked wheezing attacks in preschool children with recurrent wheezing. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was carried out between August 2007 and September 2008. The study included 75 children with recurrent wheezing who were 1 to 6 years old. Participants were randomly assigned to groups given either OM-85 BV or a placebo (1 capsule per day for 10 days each month for 3 consecutive months) at the start of the trial. Participants were followed for 12 months, which included the administration period of the test article. Results: Subjects given OM-85 BV had a lower rate of wheezing attacks. The cumulative difference in wheezing attacks between the 2 groups was 2.18 wheezing attacks per patient in 12 months; there was a 37.9% reduction in the group given OM-85 BV compared with the group given placebo (P < .001). Stepwise multiple (linear) regression analysis showed that the main difference between the OM-85 BV and placebo groups was a reduction the number of ARTIs (R = −0.805, P < .001). The duration of each wheezing attack was 2 days shorter in the group given OM-85 BV than in the group given placebo (P = .001). Conclusion: Administration of OM-85 BV significantly reduced the rate and duration of wheezing attacks in preschool children with ARTIs. [ABSTRACT FROM AUTHOR]

Abstract: The bacterial extract OM-85 BV has been shown to provide protection against recurrent respiratory infections. We here investigated its efficacy against viral and bacterial infections in murine models. We first evaluated the role of OM-85 BV protecting from an A/PR/8/34 (H1N1) influenza virus infection. In a group treated with 1.75mg/mouse OM-85 BV all animals survived, compared to 70% in the untreated control group and a group treated with a lower dosage. In addition, the appearance of clinical signs was delayed, their intensity was decreased, and they disappeared faster; also a marked increase in the influenza hemagglutination inhibition antibody level was observed. Since bacterial infections often superimpose viral lung infections, we also investigated on the protection of mice from a Salmonella typhimurium infection after the oral administration of OM-85 BV. Here, 100% of the OM-85 BV treated animals survived compared to 58% of the untreated control group. The mechanism of protection was further investigated: OM-85 BV acts, on the one hand, as an immunogen: the repeated administration of OM-85 BV induced a marked increase in serum antibody levels recognizing pathogenic bacterial strains. On the other hand, the extract acts as a stimulator of the nonspecific macrophage, monocyte, dendritic cell, and granulocyte response. Our findings demonstrate the antimicrobial activity of OM-85 BV against infections, as also has been shown in clinical studies. [ABSTRACT FROM AUTHOR]

OM-85 BV is an immunomodulatory agent used for prevention of exacerbations in persons with chronic lung disease. We conducted a systematic review of OM-85 BV to evaluate its efficacy and safety. A systematic search for relevant articles was performed. Studies were included if they involved persons with chronic obstructive pulmonary disease or chronic bronchitis and were randomized to OM-85 BV or placebo. Investigators extracted data on study design, participant characteristics, and clinical outcomes. Thirteen trials involving 2066 individuals met inclusion criteria. Three trials enrolled an older, more homogenous population with chronic obstructive pulmonary disease. Utilizing quantitative pooled analysis in these studies, with one or more acute exacerbations as the endpoint, we found a non-statistically significant trend in favor of OM-85 BV [relative risk 0.83, 95% confidence interval 0.65–1.05]. Ten trials enrolled a heterogeneous population with chronic bronchitis. In these trials, exacerbation rates were less with OM-85 BV in 4 of 9 trials reporting this outcome. Varied results in the outcomes of hospitalization, symptom scores, and antibiotic or steroid use were found across studies. Withdrawals and adverse events were similar between OM-85 BV and placebo. While OM-85 BV is used to prevent exacerbations in persons with chronic lung disease, consistent evidence across multiple important outcomes does not exist to clearly demonstrate clinical benefit. Further randomized controlled trials enrolling large numbers of persons with well-defined COPD are necessary to confirm the effectiveness of this agent. [ABSTRACT FROM AUTHOR]

Background: Oral lyophilized extracts of bacteria species have been used since the early 1970s to improve symptoms and to prevent exacerbations in COPD patients. The value of these treatments, which are thought to be immunomodulating, is poorly understood. Our aim was to quantify the efficacy of oral bacteria extracts in patients with chronic bronchitis and COPD. Design: Systematic review of randomized trials. Data sources: Electronic databases, bibliographies, and contact with authors and manufacturers. Review methods: Randomized comparisons of oral purified bacterial (active) extracts with placebo or no treatment (control) were selected. Meta-analyses were performed using fixed and random-effects models, and the results were expressed as relative risk (RB), odds ratio (OR), number needed to treat for one to benefit (NNTB), or number needed to treat for one to be harmed (NNTH), with 95% confidence interval (CI). Results: Thirteen trials (1,971 patients), most of which were of low quality, tested OM-8SBV (Broncho-Vaxom; OM Pharma; Geneva, Switzerland), LW-50020 (Luivac; ALTANA Pharma; Bad Homburg, Germany), or SL-04. Two trials (731 patients) had appropriate methodologies and reported on exacerbations. The RB in favor of the oral bacterial extract (active) was 0.83(95% CI, 0.55 to 1.25), and the NNTB was 15.4 (95% CI, 5.5 to ∞; NNTH, 27.5). Five trials (591 patients) reported on observer-assessed improvement of symptoms BR in favor of active extracts was 057 (95% CI, 0.49 to 0.66), and the NNTB was 4 (95% CI, 2.8 to 5.4). Two trials (n = 344), reported on patient-assessed improvement (RB, 0.44; 95% CI, 0.31 to 0.61) [NNTB, 4; 95% CI, 3.0 to 5.9]. In two trials (163 patients), the average duration of an exacerbation was shorter with the active extracts (weighted mean difference, -2.7 days; 95% CI, -3.5 to -1.8). Itching or cutaneous eruptions was reported in 3.3% of patients (four trials; 802 patients) who received active extracts compared with 1.0% of control subjects (OR, 2.94 95% CI, 1.12 to 7.69) [NNTH, 50; 95% CI, 14 to 161]. Urologic problems (two trials; 671 patients) were reported in 8% of patients who received active extracts compared with 3.0% of control subjects (OR, 2.62; 95% CI, 1.35 to 5.11) [NNTH, 22; 95% CI, 10 to 61]. Conclusions: Oral purified bacterial extracts improve symptoms in patients with chronic bronchitis and COPD. There is not enough evidence to suggest that they prevent exacerbations. Cutaneous and urologic adverse effects are common. [ABSTRACT FROM AUTHOR]

Introduction: Molecular antibodies (mAb) targeting inflammatory mediators are effective in T2-high asthma. The recent approval of Tezepelumab presents a novel mAb therapeutic option for those with T2-low asthma., Areas Covered: We discuss a number of clinical problems pertinent to severe asthma that are less responsive to current therapies, such as persistent airflow obstruction and airway hyperresponsiveness. We discuss selected investigational approaches, including a number of candidate therapies under investigation in two adaptive platform trials currently in progress, with particular reference to this unmet need, as well as their potential in phenotypes such as neutrophilic asthma and obese asthma, which may or may not overlap with a T2-high phenotype., Expert Opinion: The application of discrete targeting approaches to T2-low molecular phenotypes, including those phenotypes in which inflammation may not arise within the airway, has yielded variable results to date. Endotypes associated with T2-low asthma are likely to be diverse but await validation. Investigational therapeutic approaches must, likewise, be diverse if the goal of remission is to become attainable for all those living with asthma.

Background: Bronchiectasis is characterized by recurrent infectious exacerbations. No existing data inform preventive strategy for exacerbations beyond chronic macrolides. OM-85 BV, an immunostimulant, has been shown to prevent recurrent respiratory infections. We initiated this 1-year, multi-centered, double-blind, and controlled trial to investigate the PReventive effect of OM-85 BV on Bronchiectasis Exacerbations in Chinese patients (iPROBE)., Methods: Patients with bronchiectasis aged 18 to 75 years, having at least one exacerbation in the past year, were randomized to receive, in addition to any respiratory medications, two courses of 7 mg of OM-85 BV or matching placebo (one capsule orally per day for 10 days a month) for 3 consecutive months, followed by 3 months without treatment. The primary outcomes included the number of acute infectious exacerbations and the time to first exacerbation. Secondary endpoints included patient-reported respiratory outcomes. Safety measures were also assessed., Results: Among the 196 participants, 99 were in the OM-85 BV group and 97 in the placebo group. At week 52, the mean number of acute exacerbations per patient was equal to 0.98 and 0.75, respectively, in the two groups (P=0.14). Difference in the time to first pulmonary exacerbation was not statistically significant (P=0.11). There was no statistically significant difference in any secondary end-points. The safety profile in the two arms was good and the majority of adverse events were mild., Conclusions: OM-85 BV did not demonstrate protection in decreasing pulmonary exacerbations of bronchiectasis in this trial performed in Chinese patients. It had good safety profile., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-20-1662). The authors have no conflicts of interest to declare., (2021 Journal of Thoracic Disease. All rights reserved.)