Long Term Nebulised Gentamicin in Patients With Bronchiectasis

University of Edinburgh

Status and phase

Completed

Phase 4

Conditions

Bronchiectasis

Treatments

Drug: Gentamicin

Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00749866

CZB/4/451

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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