Status:
COMPLETED
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Bronchiectasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00749866
Start Date
May 1 2007
End Date
August 1 2009
Last Update
August 10 2010
Active Locations (1)
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1
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA