Prevention of OM-85 on Bronchiectasis Exacerbation

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.

Conditions

• Bronchiectasis With Acute Exacerbation

Interventions

DRUG

OM-85 BV

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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences

  lead OTHER

• Peking University

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• Tongji University

  collaborator OTHER

• Wenzhou Medical University

  collaborator OTHER

Principal Investigators

• Jinming Gao, M.D. · Peking Union Medical College Hospitak

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-01

Primary Completion

2018-11-23

Completion

2018-11-23

Countries

• China

Study Locations