Prevention of OM-85 on Bronchiectasis Exacerbation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborators:
Peking University
Capital Medical University
Tianjin Medical University
Zhejiang University
China Medical University, China
Information provided by (Responsible Party):
Jinming Gao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01968421
First received: October 17, 2013
Last updated: October 19, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Bronchiectasis With Acute Exacerbation
Drug: OM-85
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Bronchiectasis Exacerbation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    (1) the numbers of acute exacerbation; (2) percent of patients free of event-based exacerbation.


Secondary Outcome Measures:
  • Life quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    (1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)

  • Lung function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Lung function parameters: FEV1, FVC, FEV1/FVC;


Other Outcome Measures:
  • rescue medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Use of antibiotics and rapid-acting bronchodilator


Estimated Enrollment: 250
Study Start Date: December 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: OM-85
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
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.
Drug: OM-85
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968421

Contacts
Contact: Jinming Gao, M.D. 861069155049 gjinming@yahoo.com
Contact: Lili Lou, M.D. 861069155049

Locations
China
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 100730
Contact: Jinming Gao, M.D.    861069155049    gjinming@yahoo.com   
Principal Investigator: Lingfei Kong, M.D.         
Principal Investigator: Chengli Que, M.D.         
Principal Investigator: Xuefen Wang, M.D.         
Principal Investigator: Hong Zhu, M.D.         
Principal Investigator: Jie Cao, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Peking University
Capital Medical University
Tianjin Medical University
Zhejiang University
China Medical University, China
Investigators
Principal Investigator: Jinming Gao, M.D. Peking Union Medical College Hospitak
  More Information

No publications provided by Chinese Academy of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jinming Gao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01968421     History of Changes
Other Study ID Numbers: Bronchiectasis-Gao001, OM pharmaceuticals
Study First Received: October 17, 2013
Last Updated: October 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
OM-85, bronchiectasis, placebo, pulmonary exacerbation

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014