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Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Gentamicin
Saline
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Nebulised Gentamicin

Nebulised 0.9% Saline

Outcomes

Primary Outcome Measures

Reduction in bacterial load

Secondary Outcome Measures

airways and systemic inflammation
Spirometry and exercise capacity
Exacerbation frequency
Health Related Quality of Life
Long term safety with nebulised Gentamicin

Full Information

First Posted
September 8, 2008
Last Updated
August 9, 2010
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT00749866
Brief Title
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Nebulised Gentamicin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Nebulised 0.9% Saline
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Intervention Description
Nebulised 80mg twice daily
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Nebulised 4mls 0.9% Saline twice daily
Primary Outcome Measure Information:
Title
Reduction in bacterial load
Time Frame
1 year
Secondary Outcome Measure Information:
Title
airways and systemic inflammation
Time Frame
1 year
Title
Spirometry and exercise capacity
Time Frame
1 year
Title
Exacerbation frequency
Time Frame
1 year
Title
Health Related Quality of Life
Time Frame
1 Year
Title
Long term safety with nebulised Gentamicin
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam T Hill, MBChB MD
Organizational Affiliation
NHS Lothian and University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22744718
Citation
Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.
Results Reference
derived
PubMed Identifier
20870753
Citation
Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
Results Reference
derived

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Long Term Nebulised Gentamicin in Patients With Bronchiectasis

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