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

HS Lothian Health Board0 个研究点目标入组 0 人开始时间: 2006年3月3日最近更新: 2019年11月25日

适应症

试验速览

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•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

发起方

HS Lothian Health Board