Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749866
• Other study ID #: CZB/4/451
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: August 9, 2010
• Start date: May 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in bacterial load		1 year	No
Secondary	airways and systemic inflammation		1 year	No
Secondary	Spirometry and exercise capacity		1 year	No
Secondary	Exacerbation frequency		1 year	No
Secondary	Health Related Quality of Life		1 Year	No
Secondary	Long term safety with nebulised Gentamicin		1 Year	Yes