Bronchiectasis With Acute Exacerbation Clinical Trial
Official title:
To Investigate the PRevention of OM-85 on Bronchiectasis Exacerbation (iPROBE): a Multicenter, Randomised, Double-dummy, Placebo-controlled Clinical Trial in Chinese Patients
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.
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.
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