EXCALIBUR

• Research type

  Research Study

• Full title

  Treating Acute EXacerbation of COPD with Chinese HerbAL MedIcine to aid AntiBiotic Use Reduction (EXCALIBUR) - Study of Shufeng Jiedu® (SFJD) capsules to aid antibiotic use reduction in acute exacerbations of chronic obstructive pulmonary disease: a mixed-methods, double blind, randomised placebo-controlled feasibility trial

• IRAS ID

  268737

• Contact name

  Michael Moore

• Contact email

  mvm 198@soton.ac.uk

• Sponsor organisation

  University of Southampton

• ISRCTN Number

  ISRCTN26614726

• Duration of Study in the UK

  1 years, 5 months, 31 days

• Research summary

  Patients with COPD commonly experience flare-ups (“acute exacerbations”) and antibiotics are often prescribed. However, only one in three flare-ups are caused by bacterial infections and are helped by antibiotics. The remaining two out of three flare-ups are caused by viruses or environmental factors and in these cases, antibiotics will not help. If you take antibiotics, you are more likely to suffer from an infection from drug-resistant bacteria in the future, so it is important to find a safe and effective way to control the symptoms of COPD flare-ups without using antibiotics. There is evidence, based on studies conducted in China, that a herbal combination treatment called Shufeng Jiedu could help control symptoms of COPD flare-ups.
  
  We would like to know whether the herbal combination, Shufeng Jiedu, could be an alternative to antibiotics. As this study is a feasibility study, it will not answer this question but this will help us to plan a large, full-scale trial.

  COPD patients aged 40 years or older who present at their GP Practice with an acute exacerbation of COPD will be invited to take part in the EXCALIBUR trial. Eligible patients (participants) will be randomly allocated to Shufeng Jiedu (SFJD) capsules or matched placebo (dummy capsule), and will take 4 capsules, 3 times a day for 14 days.

  Participants will be asked to complete a participant diary for 28 days, recording their COPD flare-up symptoms in a symptom questionnaire and any medication they have taken for their flare-up (including the trial treatment). The participants will receive a final questionnaire mailed to them at 12 weeks post-randomisation.

  Research sites will perform a review of the participant's notes 12 weeks post-randomisation to record any further GP visits or hospital admissions.

  Participants will also be interviewed at 4 weeks to give their views on the trial documents, design, and herbal treatment.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  20/LO/0580

• Date of REC Opinion

  30 Nov 2020

• REC opinion

  Further Information Favourable Opinion