Can long term nebulised gentamicin reduce the bacterial burden, break the vicious cycle of inflammation and improve quality of life in patients with bronchiectasis? - Impact of nebulised gentamicin in patients with bronchiectasis
- Conditions
- Bronchiectasis is respiratory disease with damaged airways. Such patients have frequent bacterial chest infections. The aim of our study is to assess whether nebulised gentamicin 80mg twice daily will reduce the bacteria in the airways and make patients feel better.
- Registration Number
- EUCTR2006-000338-10-GB
- Lead Sponsor
- HS Lothian Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria
Bronchiectasis confirmed by high resolution computed tomography of the chest.
Clinically stable over the past 4 weeks
Patients between the age of 18-85 years of age
Chronic sputum production more than 5mls for the majority of days in 3 months before enrolment
Patients able to tolerate a nebulised gentamicin challenge without side effects or bronchoconstriction (see below)
Patients with an FEV1 more than 35% predicted
Smoking <20 pack year history and ex-smokers for more than 1 year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with asthma or allergic bronchopulmonary aspergillosis
Patients with COPD or active tuberculosis
Patients with cystic fibrosis
Unstable angina or uncontrolled congestive cardiac failure
Patients with ongoing malignancy
Patients with pregnancy or breast feeding
Patients unable to tolerate the nebulised gentamicin due to bronchospasm, fall in FEV1 >15% and >200mls despite the addition of nebulised Salbutamol 2.5mg pre nebulised gentamicin, or drug rash
Patients with an FEV1 less than 35% predicted
Patients with chronic renal failure with a creatinine clearance less than 30mls/minute
Patients with vestibular instability
Patients with previous side effects with aminoglycosides
Serum trough gentamicin levels trough > 1mg/L at any time point during the study
Patients chronically colonised with Pseudomonas aeruginosa that are resistant in vitro to nebulised gentamicin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method