OM-85
Immunostimulant that counters respiratory infections
From Wikipedia, the free encyclopedia
OM-85 or OM85 (trade name Broncho-Vaxom commercialised by OM Pharma) is an immunostimulant. It is a combination of molecules extracted from the walls of bacteria that commonly cause respiratory infections.[1]
| Clinical data | |
|---|---|
| Trade names | Broncho-Vaxom |
| Other names | OM 85BV |
| Identifiers | |
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Uses
It has been sold, as Broncho-Vaxom, in Europe and some South American countries.[1] It is used for children with asthma or recurrent respiratory infections.[1]
Studies have shown that OM-85 can enhance both innate and adaptive immunity by promoting the maturation of dendritic cells in the gastrointestinal Peyer's patches, which in turn strengthens immune defenses in the lung mucosa.[2]
It can also reduce inflammation. This is achieved through the reduction of pro-inflammatory cytokines and the increase of anti-inflammatory cytokines.[2]
Potential uses
Composition
It is a mix of lipopolysaccharides,[5] extracted from bacteria cell walls. These include Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus sanguinis, and Moraxella catarrhalis.[2]
Clinical trials
It has been studied in numerous pediatric clinical trials.[3]
Adults
A randomized, double-blind, placebo-controlled study in 396 patients with chronic bronchitis demonstrated a 28% reduction in RIs (Respiratory Tract Infections[2]) in patients treated with OM-85, associated with a reduction in antibiotic prescriptions, and no increase in adverse events.[2]
In a randomized, double-blind, placebo-controlled 6-month study performed in 381 patients with severe COPD and a long smoking history, OM-85 induced a 55% reduction in the number of hospitalization days for respiratory diseases compared to placebo.[2]
A subsequent randomized, double-blind, placebo-controlled trial in 273 patients aged >40 years with recently diagnosed chronic bronchitis or COPD and current exacerbation showed that the exacerbation rate was reduced by 29% with OM-85 compared to placebo. This reduction was more pronounced in patients who were smokers or ex-smokers, showing a 40% lower mean rate of exacerbation vs. placebo.[2]
A more recent study demonstrated the ability of OM-85 to protect COPD patients from exacerbations by significantly reducing the percentage of patients with exacerbations after 12 weeks of treatment and maintaining its beneficial effect until 22 weeks, with a positive tolerability profile.[2]
Children
The use of OM-85 for 10 consecutive days every month for 3 months was shown to reduce the risk of RRIs (Recurrent Respiratory Infection[2]) in children, with a favorable safety profile. The protective effect was highest in children with the highest risk, suggesting that OM-85 administration might be particularly useful and should be recommended in these subjects.[2]
A prospective, randomized, single-blind study in 68 children aged 36–59 months treated with OM-85 for 3 months with 10-day cycles and receiving influenza vaccine 15 days after the first cycle demonstrated a more pronounced reduction of upper and lower respiratory tract infections. Moreover, a reduction in antibiotic use and the number of missed school days was recorded, with no interference of OM-85 on the immune response against the influenza vaccine and no increase in adverse events.[2]
In a randomized, double-blind placebo-controlled study performed in children aged 6–13 years with ≥3 acute episodes of RIs in the 6 months before enrollment, treatment with OM-85 for 6 months induced a 52% reduction in the number of infections compared to placebo. OM-85 use was also associated with a reduction in antibiotic use, days of illness, and school absenteeism, with no increase in adverse events.[2]
A randomized, double-blind placebo-controlled study in 75 pre-school children with a history of frequent wheezing episodes demonstrated that a single OM-85 course reduced both rhinopharyngitis and wheezing episodes by 38% over 12 months, with a significant reduction in the cumulative frequency of wheezing episodes compared to placebo and in the percentage of patients using antibiotics.[2]