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

Tracking Information

First Received Date ^ICMJE

September 8, 2008

Last Updated Date

August 9, 2010

Start Date ^ICMJE

May 2007

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00749866 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Official Title ^ICMJE

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Bronchiectasis

Intervention ^ICMJE

Drug: Gentamicin
Nebulised 80mg twice daily
Drug: Saline
Nebulised 4mls 0.9% Saline twice daily

Study Arm (s)

Active Comparator: 1
Nebulised Gentamicin

Intervention: Drug: Gentamicin
Placebo Comparator: 2
Nebulised 0.9% Saline

Intervention: Drug: Saline

Publications *

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. Epub 2010 Sep 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00749866

Other Study ID Numbers ^ICMJE

CZB/4/451

Has Data Monitoring Committee

Responsible Party

Dr Adam Hill; Consultant Physician and Honorary Senior Lecturer, NHS Lothian and University of Edinburgh

Study Sponsor ^ICMJE

University of Edinburgh

Collaborators ^ICMJE

NHS Lothian

Investigators ^ICMJE

Principal Investigator:

Adam T Hill, MBChB MD

NHS Lothian and University of Edinburgh

Information Provided By

University of Edinburgh

Verification Date

August 2010

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

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