Prevention of OM-85 on Bronchiectasis Exacerbation

NCT01968421 | Completed Phase 4 Results

• 2 other identifiers: Bronchiectasis-Gao001Vifro pharmaceuticals
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiectasis With Acute Exacerbation

Keywords

OM-85, bronchiectasis, placebo, acute exacerbation

Outcome Measures

Primary Outcomes (1)

• Bronchiectasis Exacerbation

  the proportion of acute exacerbations

  1 year

Secondary Outcomes (2)

• Life Quality

  1 year

• Lung Function

  1 year

Other Outcomes (1)

• Rescue Medication

  1 year

Study Arms (2)

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.

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.

Drug: OM-85 BV

Interventions

OM-85 BV DRUG

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.

Also known as: Bronchovaxom

OM-85; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Peking University: collaborator
• Capital Medical University: collaborator
• Tianjin Medical University: collaborator
• Zhejiang University: collaborator
• China Medical University, China: collaborator
• Tongji University: collaborator
• Wenzhou Medical University: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Shanghai Tongji University

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 24773830 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Jinming Gao, Director of Clinical Trials
• Organization: Peking Union Medical College Hospital

gjinming@yahoo.com

8610691550549

Study Officials

• Jinming Gao, M.D.

  Peking Union Medical College Hospitak

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 24, 2013
• Study Start: March 1, 2015
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

CN (2)