Prevention of OM-85 on Bronchiectasis Exacerbation
Condition: Bronchiectasis With Acute Exacerbation
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the
      medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation
      and infection. Bronchiectasis airways are often colonized with bacterial species. Infections
      of the airways are thought to play an important role in bronchiectasis exacerbation. The
      non-specific prevention of recurrent airway infections by immunostimulating agents has gained
      growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important
      in respiratory infections, has shown the benefit for significantly reducing the incidence of
      exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is
      to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese
      patients (iPROBE).

      This study is designed as a prospective randomised double-blind placebo-controlled
      multi-centred trial.
    

Detailed description: 
      Bronchiectasis is still a common chronic respiratory disease. Non-cystic fibrosis
      bronchiectasis is characterized by irreversible dilatation of the medium-sized bronchi as a
      result of airway injury due to recurrent or chronic inflammation and infection. Clinical
      features of bronchiectasis include chronic production of sputum often mucopurulent or
      purulent in nature, persistent bacterial colonization, recurrent lower respiratory tract
      infections. Bronchiectasis airways are often colonized with bacterial species. Infections of
      the airways are thought to play an important role in bronchiectasis exacerbation. Progressive
      lung damage in bronchiectasis results from a 'vicious cycle' of recurrent bacterial infection
      and a deregulated inflammatory response. The non-specific prevention of recurrent airway
      infections by immunostimulating agents has gained growing scientific interest. OM-85,
      consisting extracts of eight kinds of bacteria important in respiratory infections, has been
      known to support the respiratory tract resistance to the pathogens via activating pulmonary
      macrophages, increasing the ratio of CD4 to CD8 lymphocytes, and changing the level of a
      variety of cytokines in the lung. OM-85 has shown the benefit for significantly reducing the
      incidence of exacerbations of chronic obstructive pulmonary disease (COPD). Bronchiectasis
      exacerbations contribute substantially to rapid decline in lung function, reduced quality of
      life, and the medical costs. The purpose of this study is to investigate the PReventive
      effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients (iPROBE).

      This study is designed as a prospective randomised double-blind placebo-controlled
      multi-centred trial. A total of 244 patients with bronchiectasis, who have had at least one
      exacerbation of bronchiectasis in the previous year, will be included. The subjects will be
      randomly received two courses of 7mg of OM-85 or matching placebo to take one oral capsule
      per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3
      months later with the same schedule for 1 year.

      We will investigate whether long-term therapy with an oral immunostimulant OM-85 can decrease
      exacerbations in patients with bronchiectasis over 1-year period. Besides, we will assess
      other outcomes including: the rate of event-based exacerbation, lung function parameters, the
      total scores on the St George's respiratory questionnaire and coughing, and inflammatory
      index. We hope that this study will provide novel information on the preventive effects of
      OM-85 treatment on bronchiectasis exacerbation and will address a knowledge gap for this
      poorly understood and under-studied disease.
    

Intervention name(s): OM-85 BV
Intervention type(s): Drug
Intervention description(s): two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
Other intervention name(s): Bronchovaxom
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: OM-85, bronchiectasis, placebo, acute exacerbation