Prevention of OM-85 on Bronchiectasis Exacerbation
Condition: Bronchiectasis With Acute Exacerbation
MeSH terms: Bronchiectasis
Intervention: OM-85 BV
Intervention description: 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.
Intervention MeSH terms: Broncho-Vaxom
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: OM-85, bronchiectasis, placebo, acute exacerbation

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.