Bronchiectasis With Acute ExacerbationPhase 4NCT01968421
Prevention of OM-85 on Bronchiectasis Exacerbation
A Phase 4 study testing OM-85 BV in people with Bronchiectasis With Acute Exacerbation, run by Chinese Academy of Medical Sciences at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchiectasis With Acute Exacerbation
- What is being tested?
- OM-85 BV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2015to 23 Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, 100730
Shanghai Tongji University
Shanghai
About this study
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.
Read the 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.
- Conditions
- Bronchiectasis With Acute Exacerbation
- Being tested
- OM-85 BV
- Keywords
- OM-85, bronchiectasis, placebo, acute exacerbation
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-85 BVDrug
Also called Bronchovaxom
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.
| Study group | Role | What they receive |
|---|---|---|
| OM-85 | Experimental | The subjects will be randomly received two courses of 7mg of OM-85 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. Receives: Drug: OM-85 BV |
| Placebo | Placebo comparator | The subjects will be randomly received two courses of 7mg of 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. Receives: Drug: OM-85 BV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchiectasis Exacerbation
the proportion of acute exacerbations
Measured: 1 year
Secondary outcomes (2)
Life Quality
(1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)
Measured: 1 year
Lung Function
Lung function parameters: FEV1, FVC, FEV1/FVC;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study start1 Mar 2015
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis With Acute ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Capital Medical University, Tianjin Medical University, Zhejiang University, China Medical University, China, Tongji University, Wenzhou Medical University
- Responsible party
- Principal investigator, Jinming Gao, Chinese Academy of Medical Sciences
- Investigators
- Jinming Gao, M.D., Principal investigator, Peking Union Medical College Hospitak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968421
- Sponsor's protocol ID
- Bronchiectasis-Gao001
- Other IDs
- Vifro pharmaceuticals
- Status last verified
- Apr 2020
- First submitted
- 17 Oct 2013
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao J, Gao X, Kong L. To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: study protocol for a randomized controlled trial. Trials. 2014 Apr 29;15:150. doi: 10.1186/1745-6215-15-150.
PubMed 24773830
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01968421
- Acronym / sponsor ID
- Bronchiectasis-Gao001
- Conditions
- Bronchiectasis With Acute Exacerbation
- Keywords
- OM-85, bronchiectasis, placebo, acute exacerbation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University, Capital Medical University, Tianjin Medical University, Zhejiang University, China Medical University, China, Tongji University, Wenzhou Medical University
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OM-85 | Experimental | Drug: OM-85 BVThe subjects will be randomly received two courses of 7mg of OM-85 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. |
| Placebo | Placebo comparator | Drug: OM-85 BVThe subjects will be randomly received two courses of 7mg of 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM-85 BVAlso: Bronchovaxomtwo 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. | Drug | OM-85, Placebo |
Primary outcome
Bronchiectasis Exacerbation
Time frame: 1 year
the proportion of acute exacerbations
2 secondary outcomes
Life Quality
Time frame: 1 year
Lung Function
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24773830Gao J, Gao X, Kong L. To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: study protocol for a randomized controlled trial. Trials. 2014 Apr 29;15:150. doi: 10.1186/1745-6215-15-150.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinming Gao, M.D. principal investigator
Peking Union Medical College Hospitak
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OM-85 BV in people with Bronchiectasis With Acute Exacerbation, run by Chinese Academy of Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchiectasis Exacerbation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.