Brief Title
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
Official 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Reduction in bacterial load
Secondary Outcome
airways and systemic inflammation
Condition
Bronchiectasis
Intervention
Gentamicin
Study Arms / Comparison Groups
1
Description: Nebulised Gentamicin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
May 2007
Completion Date
August 2009
Primary Completion Date
August 2009
Eligibility Criteria
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Adam T Hill, MBChB MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00749866
Organization ID
CZB/4/451
Study Sponsor
University of Edinburgh
Collaborators
NHS Lothian
Study Sponsor
Adam T Hill, MBChB MD, Principal Investigator, NHS Lothian and University of Edinburgh
Verification Date
August 2010