Long Term Nebulised Gentamicin in Patients With Bronchiectasis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00749866

Enrollment

Registered

2008-09-09

Start date

2007-05-31

Completion date

2009-08-31

Last updated

2010-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects

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.

Interventions

DRUGGentamicin

Nebulised 80mg twice daily

DRUGSaline

Nebulised 4mls 0.9% Saline twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in bacterial load	1 year

Secondary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026