Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of OM-85 on Bronchiectasis Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968421
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Peking University
Capital Medical University
Tianjin Medical University
Zhejiang University
China Medical University, China
Tongji University
Wenzhou Medical University
Information provided by (Responsible Party):
Jinming Gao, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 17, 2013
First Posted Date  ICMJE October 24, 2013
Results First Submitted Date  ICMJE July 23, 2019
Results First Posted Date  ICMJE April 21, 2020
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE March 1, 2015
Actual Primary Completion Date November 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
Bronchiectasis Exacerbation [ Time Frame: 1 year ]
the proportion of acute exacerbations
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2013)
Bronchiectasis Exacerbation [ Time Frame: 1 year ]
(1) the numbers of acute exacerbation; (2) percent of patients free of event-based exacerbation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
  • Life Quality [ Time Frame: 1 year ]
    (1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)
  • Lung Function [ Time Frame: 1 year ]
    Lung function parameters: FEV1, FVC, FEV1/FVC;
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2013)
  • Life quality [ Time Frame: 1 year ]
    (1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)
  • Lung function [ Time Frame: 1 year ]
    Lung function parameters: FEV1, FVC, FEV1/FVC;
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2020)
Rescue Medication [ Time Frame: 1 year ]
Use of antibiotics and rapid-acting bronchodilator
Original Other Pre-specified Outcome Measures
 (submitted: October 19, 2013)
rescue medication [ Time Frame: 1 year ]
Use of antibiotics and rapid-acting bronchodilator
 
Descriptive Information
Brief Title  ICMJE Prevention of OM-85 on Bronchiectasis Exacerbation
Official Title  ICMJE To Investigate the PRevention of OM-85 on Bronchiectasis Exacerbation (iPROBE): a Multicenter, Randomised, Double-dummy, Placebo-controlled Clinical Trial in Chinese Patients
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Bronchiectasis With Acute Exacerbation
Intervention  ICMJE 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.
Other Name: Bronchovaxom
Study Arms  ICMJE
  • Experimental: OM-85
    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.
    Intervention: Drug: OM-85 BV
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: OM-85 BV
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2020)
196
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2013)
250
Actual Study Completion Date  ICMJE November 23, 2018
Actual Primary Completion Date November 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968421
Other Study ID Numbers  ICMJE Bronchiectasis-Gao001
Vifro pharmaceuticals ( Other Grant/Funding Number: PUMCHGao001 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinming Gao, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE
  • Peking University
  • Capital Medical University
  • Tianjin Medical University
  • Zhejiang University
  • China Medical University, China
  • Tongji University
  • Wenzhou Medical University
Investigators  ICMJE
Principal Investigator: Jinming Gao, M.D. Peking Union Medical College Hospitak
PRS Account Chinese Academy of Medical Sciences
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP