Treating acute Exacerbation of COPD with Chinese herbal medicine to aid antibiotic use reduction (EXCALIBUR): study protocol of a randomised double-blind, placebo-controlled feasibility trial

Abstract

Background: acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are a major reason for consultations in primary care, hospital admissions, deterioration in function, and mortality. 70% of patients presenting with AECOPD in UK primary care are currently in receipt of antibiotics which is part of the standard care. However, the majority of exacerbations are not caused by bacteria. Finding effective non-antibiotic treatments for COPD exacerbations is a priority to reduce antibiotic use. The Chinese herbal medicine Shufeng Jieduâ (SFJD) has the potential to reduce treatment failure and duration of hospital stay. This study aims to test the feasibility of a randomised, double blind, placebo-controlled clinical trial on SFJD in AECOPD.

Methods: this study is a phase III, two-arm individually double blind, randomised, placebo-controlled feasibility trial with nested qualitative study, coordinated by the Southampton clinical trial unit (SCTU). Patients aged ≥40 years old, with a current AECOPD, presenting with increased sputum purulence/ volume, or breathlessness, and for whom the GP is considering use of antibiotics, will be eligible to participate. We aim to recruit seven eligible participants per month, randomise them to receive either the patent Chinese herbal medicine SFJD capsules or placebo for 14 consecutive days and to follow up for 12 weeks. The primary outcomes include the feasibility of recruitment, study retention, and the completion of trial diaries.

Discussion: if this trial demonstrates the feasibility of recruitment, delivery and follow-up, we will seek funding for a fully powered placebo-controlled trial of SFJD for the treatment of AECOPD in primary care.

Trial registration: this trial is registered via ISRCTN on 1st July 2021, identifier: ISRCTN26614726.

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Identifiers

ORCID for Merlin Willcox: orcid.org/0000-0002-5227-3444

ORCID for Nick Francis: orcid.org/0000-0001-8939-7312

ORCID for Beth Stuart: orcid.org/0000-0001-5432-7437

ORCID for Paul Little: orcid.org/0000-0003-3664-1873

ORCID for Gareth Griffiths: orcid.org/0000-0002-9579-8021

ORCID for Michael Moore: orcid.org/0000-0002-5127-4509

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