Phase 4
N=196
Prevention of OM-85 on Bronchiectasis Exacerbation
Bronchiectasis With Acute Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT01968421 ↗Enrolled (actual)
196
Serious AEs
1.5%
Results posted
Apr 2020
Primary outcome: Primary: Bronchiectasis Exacerbation — 0.98; 0.75 proportion of acute exacerbations
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OM-85 BV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chinese Academy of Medical Sciences
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bronchiectasis Exacerbation |
0.98; 0.75 | — |
| SECONDARY Life Quality |
— | — |
| SECONDARY Lung Function |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject. The Informed Consent form will be signed.
- Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator.
- Subject with both genders is adult patients (>18 years) diagnosed with bronchiectasis by high-resolution computed tomography (HRCT) of chest within 3 years of study inclusion having had at least 1 acute exacerbation in the previous year when recruiting.
Exclusion Criteria
- History of cystic fibrosis;
- Hypogammaglobulinaemia;
- Allergic bronchopulmonary aspergillosis;
- Active tuberculosis;
- Subject has been assigned to treatment in a study of the medication under investigation in this study in the previous 6 months.
- Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
- Subject has a known hypersensitivity to any components of OM85.
- Recent immunostimulant in last 3 months, cancer, stroke, severe cardiovascular disease, hepatic/kidney impairment, active TB, immuno-related diseases (RA and inflammatory bowel diseases), active ABPA.
- Subjects are free to withdraw from the study at any time, without prejudice to their continued care.
- Subject develops an illness that would interfere with his/her continued participation.
- Subject is noncompliant with the study procedures or medications in the opinion of the investigator.
- Subject takes prohibited concomitant medications as defined in this protocol (flu vaccine and pneumococcal vaccine).
- Subject withdraws his/her consent.
- There will have a confirmation of a pregnancy during the study, as evidenced by a positive pregnancy test.
- The sponsor or a regulatory agency requests withdrawal of the subject.
Data sourced from ClinicalTrials.gov (NCT01968421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.