Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease
Conditions
Interventions
OVERVIEW
This is a multicentre, double blind placebo-controlled feasibility trial of Shufeng Jiedu® in treating symptoms of acute exacerbations of COPD (AECOPD). This trial will also contain nested qu
increased sputum volume
increased breathlessness), and the GP is considering use of antibiotics.
IDENTIFICATION
Potential participants will be made aware of the EXCALIBUR trial via mail-out from the 8 recruiting GP sites. T
or no antibiotics on the trial based on the clinical assessment of the patient and their symptoms.
PARTICIPANT DIARY
Participants will be asked to complete daily diary data for up
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has a current acute exacerbation of COPD with at least one of the following: 1.1. Increased sputum purulence; 1.2. Increased sputum volume; 1.3. Increased breathlessness. 2. The current acute exacerbation has lasted for at least 24 hours and no longer than 21 days. 3. The responsible clinician is considering use of antibiotics for the acute exacerbation. 4. Diagnosis of COPD in clinical record. 5. Age 40 years or more. 6. Able to provide informed consent. 7. Able to provide the primary outcome data at 2 and 4 weeks within the expected windows.
Exclusion criteria
Exclusion criteria: 1. The responsible clinician feels urgent referral to hospital is necessary. 2. Severe illness (e.g. suspected pneumonia or pulmonary embolism or lung cancer; necessity for emergency admission to hospital). 3. Patient has a primary diagnosis of bronchiectasis, lung cancer or other active chronic respiratory disease. 4. Currently on or has previously had antibiotics or corticosteroids for this AECOPD. 5. Patient is on a maintenance dose of antibiotics for treatment of COPD. 6. Known or suspected pregnancy. 7. Women of childbearing potential who are at risk of pregnancy and not using an effective form of contraception. 8. Currently breast-feeding. 9. Chronic kidney disease stage 4 or 5. 10. Severe liver disease. 11. Cannot read or understand the study materials. 12. Previously recruited into this “EXCALIBUR” trial. 13. Previously been recruited into another drug trial within the last 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number and proportion of patients on the COPD register who present with AECOPD measured using: Onsite screening logs – proportion of patients on the COPD register who present to their GP practice with AECOPD and are considered for eligibility into EXCALIBUR 2. Proportion of patients presenting with AECOPD that are eligible and ineligible (plus reasons) for the trialmeasured using: Onsite screening logs – proportion of patients approached who agreed to be assessed for eligibility and are found eligible for inclusion 3. Proportion of eligible patients recruited measured using: Onsite screening logs – proportion of eligible patients who are recruited to the trial and eligible patients refusing to enter the trial (plus reasons why) and patient feedback from qualitative interviews. 4. Recruitment rate per site per month open measured using: Onsite enrolment logs – number of participants recruited per site per 1000 registered patients per month open. 5. Compliance with medication according to diary data and returned medication measured using: Medication adherence collected from medication diary and returned medication. Qualitative: Patient experiences of taking SFJD from qualitative interviews 6. Average no. of capsules taken per day per patient measured using: Number of capsules recorded in medication diary and in returned medication. 7. Duration of treatment per patient measured using: Number of days trial medication taken as per medication diary and in returned medication. 8. % of patients correctly guessing treatment/placebo allocation and reasons why measured using % of patients who correctly guessed whether they had been allocated to SFJD or placebo and reasons why (as reported in medication diaries and qualitative interviews). 9. % of patients returning trial diaries measured using: Percentage of patients returning diaries and patient experiences of completing the diary 10. % of diary completion measured using: Percentage of diary completion per patient and pati | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactTom Oliver
Outcome results
None listed