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

Conference:

2020 SW SAPC Bristol

Talk Code:

2D.5

Presenter:

Tom Oliver

Co-authors:

Tom Oliver, Xiao-Yang Hu, Merlin Willcox, Nick Francis, Mike Thomas, Beth Stuart, Gareth Griffiths, Jessima Hunter, Neville Goward, Mike Moore

Author institutions:

University of Southampton

Problem

Antimicrobial resistance is rising and is linked to prescribing in primary care. Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) accounts for over two million antibiotic prescriptions each year in the UK with over 70% of patients presenting with an AECOPD being prescribed antibiotics. However, many exacerbations are triggered by non-bacterial causes (e.g. viral infections, environmental factors) and there is evidence that many patients in primary care with AECOPD do not benefit from antibiotic treatment. Identifying a safe and effective method of symptom control could possibly reduce antibiotic use for AECOPD. Shufung Jiedu (SFJD), a patented Traditional Chinese Medicine consisting of 8 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 number of antibiotic courses prescribed. EXCALIBUR is a Phase III feasibility trial with the objective to determine the feasibility of conducting a full trial of SFJD in addition to best current practice for AECOPD in UK primary care.

Approach

EXCALIBUR is a multicentre, double-blind, randomised placebo-controlled feasibility trial, incorporating a nested qualitative study.Patients, aged ≥40 years with a clinical diagnosis of COPD, will be invited to participate if they present to their GP with a current AECOPD (≤21 days) with at least one of increased sputum purulence, sputum production or breathlessness for which the GP is considering use of antibiotics. 80 participants from 10 GP practices, will be randomised to one of two groups:1) Control: Usual care plus placebo capsules 2) Intervention: Usual care plus SFJD capsules.In addition to the above, GPs will be able to offer one of 3 antibiotic options: 1) Immediate2) Delayed3) None Delayed prescribing would be encouraged when appropriate.Participants will complete a symptom/treatment diary for up to 28 days and quality of life questionnaires at intervals over 12 weeks following randomisation. A medical note review to record subsequent visits to GP with AECOPD and prescribed medication and hospital admissions within 12-week follow up period will be undertaken. Qualitative interviews will be conducted with eligible patients to get feedback from patients on the feasibility of undertaking a full RCT and to determine the barriers to the implementation of a delayed antibiotic prescription and use of herbal medication.

Findings

The trial is scheduled to open to recruitment in April 2020. Trial results will inform the design of the full RCT.

Consequences

If this feasibility study leads to a successful full RCT that shows SFJD is an effective treatment for AECOPD, prescription of antibiotics for AECOPD may decline.

Submitted by:

Catherine Simpson

Funding acknowledgement:

This trial is primarily funded by the Department of Health and Social Care via Innovate UK with additional financial support from Phoenix Medical Ltd. Trial medication is provided by Anhui Jiren Pharmaceutical Co., Ltd. China.