Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Study Overview
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Brief Summary
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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.

Official Title
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Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: Gentamicin
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Nebulised Gentamicin | Drug: Gentamicin<br>* Nebulised 80mg twice daily<br>|
| Placebo Comparator: 2<br>Nebulised 0.9% Saline | Drug: Saline<br>* Nebulised 4mls 0.9% Saline twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in bacterial load |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airways and systemic inflammation |  | 1 year | 
| Spirometry and exercise capacity |  | 1 year | 
| Exacerbation frequency |  | 1 year | 
| Health Related Quality of Life |  | 1 Year | 
| Long term safety with nebulised Gentamicin |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects