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Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Information source: University of Edinburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiectasis

Intervention: Gentamicin (Drug); Saline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Edinburgh

Official(s) and/or principal investigator(s):
Adam T Hill, MBChB MD, Principal Investigator, Affiliation: NHS Lothian and University of Edinburgh

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.

Clinical Details

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

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

Primary outcome: Reduction in bacterial load

Secondary outcome:

airways and systemic inflammation

Spirometry and exercise capacity

Exacerbation frequency

Health Related Quality of Life

Long term safety with nebulised Gentamicin

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Royal Infirmary of Edinburgh, Edinburgh, Lothian EH16 4SA, United Kingdom
Additional Information

Starting date: May 2007
Last updated: August 9, 2010

Page last updated: August 23, 2015

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