OM-85 (brand name, Broncho-Vaxom) is an immunostimulant that, by boosting the immune system, works to increase a person’s natural defenses against a variety of respiratory pathogens. In clinical trials, it has been shown to reduce the incidence of exacerbations in people with COPD.
Researchers are now investigating if people with bronchiectasis, whose airways are frequently colonized by bacteria, may also experience fewer acute flares if treated with OM-85.
How OM-85 works
OM-85 is an oral treatment that consists of an extract of eight different kinds of bacteria involved in respiratory infections. The production of antibodies in the respiratory system can be divided into five stages, starting at the digestive level, where the process of activating the immune system begins. Then, the major cells involved in the body defense, lymphocytes B and T, are activated. These cells circulate in the blood and lymphatic vessels until they reach the respiratory tract, where specific antibodies (IgG) are produced locally, enhancing the body’s defense against recurrent respiratory infections.
OM-85 has protective effects because it induces the synthesis of antibodies, and at the cellular level stimulates the production of phagocytes (cells that ingest foreign particles, including as bacteria, carbon or dust) that work to destroy invading pathogens.
Phase 3 study of OM-85 in bronchiectasis
A Phase 3 study taking place in China, called iPROBE (NCT01968421) is currently investigating the effectiveness of OM-85 in reducing acute exacerbations over one year in about 240 bronchiectasis patients. Participants in this double-blind trial, expected to end in February 2018, will be given either two courses of oral OM-85, 7 mg, or placebo.
Its primary objectives are the number of acute exacerbations or flares recorded, and the percentage of participants without flares.
Secondary measures will look at improvements in quality of life (using the St. Georges Respiratory Questionnaire, or SGRQ) and in lung function, as measured by the FEV1 and FVC. An assessment will also made of the need for rescue medication, as measured by the use of antibiotics and rapid-acting bronchodilators.
Researchers in the iPROBE study suggest the treatment will help to heal airways in bronchiectasis patients by reducing airway inflammation, thereby modifying the long-term course of this disease.
OM-85 is known to have a good safety profile, and has been used in Europe for over 40 years to treat recurrent respiratory infections. Side effects are not common, with an overall incidence in clinical trials of between 3% and 4%, but can include nausea, abdominal pain, vomiting, skin rashes and coughing or dyspnea.
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