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The University of Southampton
Southampton Clinical Trials Unit

EXCALIBUR

Title

Treating Acute EXacerbation of COPD with Chinese HerbAL MedIcine to aid AntiBiotic Use Reduction

 

Description

Antimicrobial resistance is rising and is linked to prescribing in primary care. In the UK, acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) account for over two million antibiotic prescriptions each year, with over 70% of patients presenting to their GP with an AECOPD being prescribed antibiotics. However, many exacerbations are triggered by non-bacterial causes such as viral infections or enviromental factors and there is evidence that many patients in primary care with AECOPD may not benefit from antibiotic treatment. By identifying a safe and effective method of symptom control, antibiotic use for AECOPD could be reduced.

Shufung Jiedu (SFJD), a patented Traditional Chinese Medicine consisting of eight traditional Chinese herbs, is already widely used in China for the treatment of respiratory infections. Preliminary research in China suggests that in combination with usual care it can reduce the risk of relapse and duration of hospitalisation in patients with AECOPD. We think that the addition of SFJD to standard care may aid patients to recover faster and so reduce the necessity for antibiotics. A reduction in the use of antibiotics has the potential to reduce the risk of development of antimicrobial resistance.

EXCALIBUR is a Phase III feasibility trial of SFJD in addition to best current practice for the treatment of AECOPD in UK primary care.

 

Objectives

The objective is to determine the feasibility of conducting a full trial of SFJD in addition to best current practice for AECOPD in UK primary care.

 

Trial Design

EXCALIBUR is a multicentre, double-blind, randomised placebo-controlled feasibility trial, incorporating a nested qualitative study.

In addition to receiving the current best practice usual care, 80 patients will be randomised to receive either SFJD capsules or placebo capsules (4 capsules to be taken three times a day). Clinicians will be able to offer one of three antibiotic strategies in addition to the randomised intervention – immediate, delayed or no antibiotics. Delayed prescribing would be encouraged where appropriate.  

Patients will be asked to complete a symptom and treatment diary for up to four weeks and quality of life questionnaires at intervals over the 12-weeks following randomisation.  A medical notes review will be undertaken to record subsequent visits to the GP with AECOPD, antibiotics and other medications prescribed for treatment of AECOPD and hospital admissions within the 12-week follow-up period.

Eligible patients will be invited to participate in interviews to find out what they think about the use of antibiotics and herbal medicines for the treatment of AECOPD. In addition, those who took part in the study will be asked about their experiences of the EXCALIBUr trial and those who declined to take part will be asked about their reasons for not participating.

 

Trial Status

In set-up

 

Population

Adults 40 years and over with a clinical diagnosis of COPD who present to their GP with a current acute exacerbation that has lasted for at least 24 hours and no longer than 21 days and with at least one of increased sputum purulence, sputum volume or breathlessness for which the GP is considering the use of antibiotics.

 

Trial Team:

Senior Trial Manager: 

Catherine Simpson   Telephone number 023 8120 5171 

Trial Manager:

Tom Oliver   Telephone Number 023 8120 5334 

Clinical Data Coordinator:

tbc

Contact information

Email:  EXCALIBUR@soton.ac.uk

Fax:  0844 7740621 

SAE Reporting:   ctu@soton.ac.uk

 

Essential Trial Documents

 

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