Study of Shufeng Jiedu® (SFJD) capsules to aid antibiotic use reduction in acute exacerbations of chronic obstructive pulmonary disease

Phase 3

Completed

• Conditions: Chronic obstructive pulmonary disease; Respiratory

• Registration Number: ISRCTN26614726
• Lead Sponsor: niversity of Southampton

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36536462/ (added 20/12/2022) 2023 Results article in https://doi.org/10.3389/fphar.2023.1221905 (added 06/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-01
• Study Completion: 2022-12-30
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified