Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Phase 4

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: Saline; Drug: Gentamicin

• Registration Number: NCT00749866
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-09
• Last Update Posted: 2010-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Saline	Nebulised 0.9% Saline
1	Gentamicin	Nebulised Gentamicin

Primary Outcome Measures

Name	Time	Method
Reduction in bacterial load	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom