NCT00749866CompletedPhase 4
Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduction in bacterial load
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Active Comparator
Nebulised Gentamicin
Intervention: Gentamicin (Drug)
2
Placebo Comparator
Nebulised 0.9% Saline
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Reduction in bacterial load
Time Frame: 1 year
Secondary Outcomes
- Health Related Quality of Life(1 Year)
- airways and systemic inflammation(1 year)
- Spirometry and exercise capacity(1 year)
- Exacerbation frequency(1 year)
- Long term safety with nebulised Gentamicin(1 Year)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
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 bronchiectasisBronchiectasis 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.EUCTR2006-000338-10-GBHS Lothian Health Board
Recruiting
Phase 2
Investigating the preventive effect of ethanol and gentamicin in central venous catheter infectioIRCT20221129056657N3Mashhad University of Medical Sciences228
Completed
Phase 3
Gentamycin nebulisation to decrease infection in tracheostomy patientsCTRI/2022/03/041202AIIMS Bhubaneswar70
Completed
Phase 2
A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune SystemHIV InfectionGastrointestinal SymptomsNCT01184456AIDS Healthcare Foundation24
Completed
Phase 3
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency DiseasesPrimary Immunodeficiency DiseasesNCT01012323Octapharma51