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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
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Reduction in bacterial load [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749866

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

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Adam Hill; Consultant Physician and Honorary Senior Lecturer, NHS Lothian and University of Edinburgh
ClinicalTrials.gov Identifier: NCT00749866     History of Changes
Other Study ID Numbers: CZB/4/451
Study First Received: September 8, 2008
Last Updated: August 9, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Bronchiectasis
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes
Gentamicins
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013