Please select the eligibility criteria that correspond to the clinical trial below.
Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Brief Summary: The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Options:
A: Inclusion Criteria:

* Female of non child bearing potential
* Clinical diagnosis of bronchiectasis
* Be sputum producers, with history of chronic expectoration on most days

Exclusion Criteria:

* Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
* FEV1 of \<30% of predicted normal
B: Inclusion Criteria:

* Have provided written informed consent to participate in the study in accordance with the local ethics committee regulations
* Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have chronic sputum production, defined as a greater than 45 mililitres volume produced in the 1 week prior to study entry.
* Be able to perform reproducible spirometry
* Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by the absence of the following: respiratory exacerbations requiring hospitalisation, change in cough and/or sputum production, new or increased hemoptysis, more than 10% weight loss, use of additional antibiotic courses

Exclusion Criteria:

* Subjects will be excluded if one or more of the following criteria occur. The subject: Is an investigator, or an immediate family member of an investigator
* Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a sweat test result more than 60mmol/L
* Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory exacerbation requiring hospitalisation or additional course of antibiotics in the 6 weeks prior to study entry
* Has been prescribed or used oral steroids on any occasion for the 3 months prior to study entry.
* Has been using mucolytic agents on any occasion for the 2 months prior to study entry Has active tuberculosis
* Has an active malignancy, including melanoma (other skin carcinomas excluded)
* Has a history of significant liver disease or insufficiency Has a significant history of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or allergy to macrolides
* Has been participating in another interventional drug study in the 3 months prior to enrolment into this study
C: Inclusion Criteria:

* Bronchiectasis confirmed by HRCT of the chest
* Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
* Aged 18-70
* Chronic sputum production \> 5 mls for the majority of days in 3 months before enrolment
* Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
* At least two exacerbations in the past year
* Patients able to tolerate a nebulized gentamicin challenge
* FEV1 \> 30% predicted
* Smoking \< 20 pack year history and ex-smokers \>1 year.

Exclusion Criteria:

* Cystic fibrosis
* Emphysema on HRCT chest
* Thoracic surgery within the past 1 year
* Allergic bronchopulmonary aspergillosis
* Poorly controlled asthma ( \> 20% diurnal variation in peak expiratory flows despite treatment)
* Unstable angina or uncontrolled congestive cardiac failure
* Active malignancy
* Pregnancy or breast feeding
* Creatinine clearance \< 30 mls/minute
* Vestibular instability
* Previous documented intolerance to aminoglycosides
D: 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.

Answer: C