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Long Term Nebulised Gentamicin in Patients With Bronchiectasis

This study has been completed.
NHS Lothian
Information provided by:
University of Edinburgh Identifier:
First received: September 8, 2008
Last updated: August 9, 2010
Last verified: August 2010
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.

Condition Intervention Phase
Bronchiectasis Drug: Gentamicin Drug: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis

Resource links provided by NLM:

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Reduction in bacterial load [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • airways and systemic inflammation [ Time Frame: 1 year ]
  • Spirometry and exercise capacity [ Time Frame: 1 year ]
  • Exacerbation frequency [ Time Frame: 1 year ]
  • Health Related Quality of Life [ Time Frame: 1 Year ]
  • Long term safety with nebulised Gentamicin [ Time Frame: 1 Year ]

Enrollment: 60
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Nebulised Gentamicin
Drug: Gentamicin
Nebulised 80mg twice daily
Placebo Comparator: 2
Nebulised 0.9% Saline
Drug: Saline
Nebulised 4mls 0.9% Saline twice daily


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00749866

United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian and University of Edinburgh
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Adam Hill; Consultant Physician and Honorary Senior Lecturer, NHS Lothian and University of Edinburgh Identifier: NCT00749866     History of Changes
Other Study ID Numbers: CZB/4/451
Study First Received: September 8, 2008
Last Updated: August 9, 2010

Keywords provided by University of Edinburgh:
Nebulised antibiotics
Non cystic fibrosis bronchiectasis
Bacterial Load
Quality of Life
Side Effects

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017