Long Term Nebulised Gentamicin in Patients With Bronchiectasis

This study has been completed.
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00749866
First received: September 8, 2008
Last updated: August 9, 2010
Last verified: August 2010

September 8, 2008
August 9, 2010
May 2007
August 2009   (final data collection date for primary outcome measure)
Reduction in bacterial load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00749866 on ClinicalTrials.gov Archive Site
  • airways and systemic inflammation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Spirometry and exercise capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Exacerbation frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Long term safety with nebulised Gentamicin [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Bronchiectasis
  • Drug: Gentamicin
    Nebulised 80mg twice daily
  • Drug: Saline
    Nebulised 4mls 0.9% Saline twice daily
  • Active Comparator: 1
    Nebulised Gentamicin
    Intervention: Drug: Gentamicin
  • Placebo Comparator: 2
    Nebulised 0.9% Saline
    Intervention: Drug: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00749866
CZB/4/451
No
Dr Adam Hill; Consultant Physician and Honorary Senior Lecturer, NHS Lothian and University of Edinburgh
University of Edinburgh
NHS Lothian
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian and University of Edinburgh
University of Edinburgh
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP