NCT00749866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

September 8, 2008

Last Update Submit

August 9, 2010

Conditions

Bronchiectasis

Keywords

Nebulised antibioticsNon cystic fibrosis bronchiectasisBacterial LoadInflammationQuality of LifeSide Effects

Outcome Measures

Primary Outcomes (1)

  • Reduction in bacterial load

    1 year

Secondary Outcomes (5)

  • airways and systemic inflammation

    1 year

  • Spirometry and exercise capacity

    1 year

  • Exacerbation frequency

    1 year

  • Health Related Quality of Life

    1 Year

  • Long term safety with nebulised Gentamicin

    1 Year

Study Arms (2)

1

ACTIVE COMPARATOR

Nebulised Gentamicin

Drug: Gentamicin

2

PLACEBO COMPARATOR

Nebulised 0.9% Saline

Drug: Saline

Interventions

GentamicinDRUG

Nebulised 80mg twice daily

1
SalineDRUG

Nebulised 4mls 0.9% Saline twice daily

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (2)

  • Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.

    PMID: 22744718DERIVED

  • 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. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.

    PMID: 20870753DERIVED

MeSH Terms

Conditions

BronchiectasisInflammation

Interventions

GentamicinsSodium Chloride

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Adam T Hill, MBChB MD

    NHS Lothian and University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 10, 2010

Record last verified: 2010-08

Locations

GB(1)