Long Term Nebulised Gentamicin in Patients With Bronchiectasis

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Bronchiectasis
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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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Reduction in bacterial load

Secondary Outcome

 airways and systemic inflammation

Condition

Bronchiectasis

Intervention

Gentamicin

Study Arms / Comparison Groups

 1
Description:  Nebulised Gentamicin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

May 2007

Completion Date

August 2009

Primary Completion Date

August 2009

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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Adam T Hill, MBChB MD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT00749866

Organization ID

CZB/4/451

Study Sponsor

University of Edinburgh

Collaborators

 NHS Lothian

Study Sponsor

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

Verification Date

August 2010