Skip to main navigationSkip to main content
The University of Southampton
Southampton Clinical Trials Unit



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


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.


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

Open to recruitment


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: 


Trial Manager:

Tom Oliver

Clinical Data Coordinator:



Contact information:


SAE Reporting:  



Essential Trial Documents

EXCALIBUR - Protocol V4 28-Jul-2021

EXCALIBUR - Patient Information Sheet V4 02-Aug-2021

EXCALIBUR - Summary Patient Information Sheet (GP Practice) V2 05-Nov-2020

EXCALIBUR - Summary Patient Information Sheet (Mail Out) V2 05-Nov-2020

EXCALIBUR - Informed Consent Form V4 02-Aug-2021

EXCALIBUR - Eligibility/Randomisation Form V2 15-Jul-2021

EXCALIBUR - Baseline Worksheet V2 26-Aug-2021

EXCALIBUR - Participant Diary V2 15-Jul-2021

EXCALIBUR - Qualitative Invitation Letter (GP Practice) V1 07-Feb-2020

EXCALIBUR - Participant Invite Letter (Mail Out) V2 02-Aug-2021

EXCALIBUR - GP Poster V1 10-Feb-2020

EXCALIBUR - Patient Contact Details Proforma V2 02-Aug-2021

EXCALIBUR - Pregnancy Informed Consent Form V2 09-Aug-2021

EXCALIBUR - Pregnancy Patient Information Sheet V1 25-Feb-2021

EXCALIBUR - SFJD Patient Medication Information Leaflet V2 06-Nov-2020

EXCALIBUR - Patient Emergency Trial Card V1 10-Feb-2020

EXCALIBUR - Prompt Sheet for Clinicians V2 11-Aug-2021


Investigator Site File Documents

EXCALIBUR - Investigator Site File Index V1 10-Oct-2021

EXCALIBUR - Study Contacts and Information Page V1 10-Aug-2021

EXCALIBUR - Master Patient List V1 10-Aug-2021

EXCALIBUR - Screening Log V1 11-Aug-2021

EXCALIBUR - Site Delegation Log V2 11-Aug-2021

EXCALIBUR - Site Training Log V1 11-Aug-2021

EXCALIBUR - Site Visit Log V1 20-Oct-2021


Safety Documents

EXCALIBUR - SAE&SUSAR Report Form V1 11-Aug-2021

EXCALIBUR - Instructions for Completion of SAE Report V1 11-Aug-2021

EXCALIBUR - SFJD Safety Dossier V1 29-Oct-2020

EXCALIBUR - GP Safety Summary V2 06-Nov-2020

EXCALIBUR - Trial Unblinding Process V1 10-Feb-2020


Treatment Documents

EXCALIBUR - IMP Handling V1 07-Oct-2021

EXCALIBUR - IMP Storage Assessment Form V1 05-Oct-2021

EXCALIBUR - Site Drug Accountability Log V1 05-Oct-21

EXCALIBUR - Dispatch Form V1 05-Oct-2021


Privacy Settings