Long Term Nebulised Gentamicin in Patients With Bronchiectasis

August 9, 2010 updated by: University of Edinburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in bacterial load
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Adam T Hill, MBChB MD, NHS Lothian and University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZB/4/451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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