Prevention of OM-85 on Bronchiectasis Exacerbation
Status:
Completed
Trial end date:
2018-11-23
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborators:
Capital Medical University China Medical University, China Peking University Tianjin Medical University Tongji University Wenzhou Medical University Zhejiang University