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.
Conditions
Interventions
Product Name: Gentamicin
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour, liquid
Route of adminis
Sponsors
NHS Lothian Health Board
Edinburgh Research and Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of our study is to assess whether nebulised gentamicin 80mg twice daily will reduce the bacteria in the airways, limit airways and systemic inflammation, resulting in improved health related quality of life. primary endpoint 1] quantitative sputum microbiology assessing both microbial clearance and change in microbial load ; Secondary Objective: The effect of nebulised gentamicin over 1 year on the following: secondary endpoints 1] airways inflammation 2] systemic inflammatory markers 3] pulmonary physiology 4] Borg breathlessness score and St George`s Respiratory Questionnaire 5] 24 hour sputum volume 6] Use of health care resources (GP visits, A+E attendances and in-patient stay) ; Primary end point(s): primary endpoint 1] quantitative sputum microbiology assessing both microbial clearance and change in microbial load | — |
Countries
United Kingdom
Outcome results
None listed