A clinical trial to evaluate the efficacy and safety of Shufeng Jiedu capsule in acute exacerbation of chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN99049821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99049821 |
- Submission date
- 26/09/2021
- Registration date
- 07/10/2021
- Last edited
- 08/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that cause breathing difficulties. 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. There is evidence, based on studies conducted in China, that an 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 improve symptoms, and reduce the use for antibiotics.
Who can participate?
COPD patients aged 40 years or older who with a moderate or severe hospitalized acute exacerbation of COPD will be invited to take part in this trial.
What does the study involve?
Eligible patients (participants) will be randomly allocated to SFJD plus usual care or placebo (dummy capsule) plus usual care, and SFJD (placebo) will take 4 capsules, 3 times a day for 7 days. Participants will be asked to complete a participant diary for 56 days after day of meeting discharge criteria, recording their COPD flare-up symptoms and quality of life in questionnaires and any medication they have taken for their flare-up.
What are the possible benefits and risks of participating?
It is not known whether you will have any additional benefit from taking part in this trial. However, your participation will give important information about how best to treat people with flare-ups of their COPD.
You may experience mild side effects from taking the trial medication.
Where is the study run from?
Beijing University of Chinese Medicine (China)
When is the study starting and how long is it expected to run for?
August 2019 to June 2024
Who is funding the study?
National Key Research and Development Project (China)
Who is the main contact?
Ruyu Xia, xiary@bucm.edu.cn
Contact information
Scientific
Beijing University of Chinese Medicine
No.11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
| Phone | +86 3718004410 |
|---|---|
| liujp@bucm.edu.cn |
Scientific
Beijing University of Chinese Medicine
No.11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
 ORCID ID |
0000-0001-9828-5195 |
|---|---|
| Phone | +86 8510250239 |
| xiary@bucm.edu.cn |
Study information
| Study design | Multicenter interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A multicentre, randomised, double-blind, controlled trial to evaluate the efficacy and safety of Shufeng Jiedu capsule in acute exacerbation of COPD |
| Study objectives | Shufeng Jiedu (SFJD) capsule will improve symptoms in people with acute exacerbation of COPD, and will therefore reduce the use for antibiotics, the duration of admission to hospital, and the risk of relapse. |
| Ethics approval(s) | Approved 16/09/2021, Clinical Medical Research Ethics Committee of the First Affiliated Hospital, Anhui Medical University (No.218, First Affiliated Hospital of Anhui Medical University, Jixi Road, Hefei, 230022, China; +86 (0)551-62923537; 331417268@qq.com), ref: 安医一附院伦审—快—PJ2021-12-31 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Shufeng Jiedu capsule (4 capsules tid for 7 days) plus usual care will be used in the experimental group. Placebo (4 capsules tid for 7 days) plus usual care will be used in the control group. Usual care may include glucocorticoids, bronchodilators, oxygen therapy, and antibiotics. The study consists of the baseline visit, 7 days treatment period, followed by the EOT (End-of-Therapy, day 8), and LFU (Late Follow-up: 14 days after meeting discharge criteria,28 days after meeting discharge criteria, and 56 days after meeting discharge criteria) visits. Randomisation: A stratified, blocked random sequence is generated by R software. Drug containers prepared by an independent pharmacy were sequentially numbered and opened sequentially. Containers were of identical appearance, tamper-proof and equal in weight. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Shufeng Jiedu capsule |
| Primary outcome measure | Severity of clinical symptoms is measured using the EXACT-PRO score at the end of treatment on day 8. |
| Secondary outcome measures | 1. Clinical symptoms measured using CAT scores at end of treatment; EXACT-PRO scores and CAT scores at day of meeting discharge criteria and three follow-up time points (day of meeting discharge criteria + 14 days, day of meeting discharge criteria + 28 days, day of meeting discharge criteria + 56 days); EXACT-PRO frequency and duration of symptom-defined events, and severity of symptoms. 2. QoL measured using SGRQ and EQ-5D at end of treatment; EQ-5D scores at day of meeting discharge criteria, day of meeting discharge criteria + 14 days, day of meeting discharge criteria + 28 days, day of meeting discharge criteria + 56 days. 3. Length of stay (LOS) measured using the duration from admission to meeting discharge criteria. 4. A total dose of antibiotics measured using DDDs. 5. The frequency of recurrence of acute exacerbations of COPD during follow-up 8 weeks (including medical consultation or admission). 6. Hematologic biomarkers (full blood count, inflammation factors) absolute value and change from baseline at end of treatment. 7. Death during hospitalization or follow-up measured using patient records 8. Safety measured using adverse event (AE) and adverse drug reaction (ADR) measured using patient records throughout the study period |
| Overall study start date | 01/08/2019 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300 |
| Key inclusion criteria | 1. Diagnosis of COPD or has been diagnosed in clinical record. 2. Has a current acute exacerbation of COPD with at least one of the following: 2.1. Increased sputum purulence 2.2. Increased sputum volume 2.3. Increased breathlessness 3. The patient with moderate or severe hospitalized acute exacerbation of COPD (FEV1%: 30% to 80%). 4. Males and females 40 or more years of age. 5. Patient must provide written informed consent prior to any study-specific procedures, and willingness and ability to comply with all study procedures. |
| Key exclusion criteria | 1. Severe pulmonary illness (e.g. needed mechanical ventilation treatment, or necessity for admission to ICU). 2. Patient has a primary diagnosis of bronchiectasis, lung cancer or other active chronic respiratory disease. 3. Pleural empyema (not including non-purulent parapneumonic effusions). 4. Neoplastic lung disease, cystic fibrosis, progressively fatal disease, chronic neurological disorder preventing clearance of pulmonary secretions, or life expectancy of less than or equal to 3 months. 5. Carcinoma. 6. Past or current history of epilepsy or seizure disorder. 7. Severe liver disease, haematological, or immunologic disease. 8. Severely impaired renal function (CLCR ≤30 mL/min) estimated by the Cockcroft Gault formula. 9. Evidence of immediately life-threatening disease, including, but not limited to, current or impending respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (eg, diabetic ketoacidosis), or acute cerebrovascular events. 10. Confirmed or suspected respiratory tract infections attributable to sources other than acute exacerbation of COPD (eg, pneumonia), non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure). 11. Requirement for concomitant antimicrobial or systemic antifungal therapy for any reason. EXCEPTIONS: topical antifungal or antimicrobial therapy, a single oral dose of any antifungal for treatment of vaginal candidiasis 12. Infections or conditions requiring concomitant systemic corticosteroids. EXCEPTION: the corticosteroid dose equivalent is less than 40 mg prednisone per day. 13. Previous treatment with an antimicrobial or corticosteroids for treatment of this acute exacerbation of COPD more than 72 hours leading up to admission. 14. Use traditional Chinese medicine as therapy for this acute exacerbation of COPD. 15. Probenecid administration within 3 days prior to initiation of the study treatment regimen or requirement for concomitant therapy with probenecid. 16. Women who are pregnant (confirmed by a urine pregnancy test) or lactating. Women of childbearing potential who are at risk of pregnancy and not using an effective form of contraception. 17. History of any hypersensitivity or allergic reaction to SFJD or composition of SFJD. 18. Hospitalization within 14 days prior to onset of symptoms. 19. Previously been recruited into another drug trial within the last 6 weeks. 20. Involvement in the planning and/or conduct of the study (applies to Jiren staff and their representatives). |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Hefei
230022
China
Dongcheng District
Beijing
100700
China
Minhang District
Shanghai
200240
China
Sponsor information
University/education
No.11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
| Phone | +86 8710023307 |
|---|---|
| fanyixin713@126.com | |
| Website | http://www.bucm.edu.cn/ |
"ROR" |
https://ror.org/05damtm70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese Ministry of Science and Technology, Ministry of Science & Technology, People Republic of China, 中华人民共和国科学技术部, Ministry of Science and Technology (China), State Science and Technology Commission, MOST
- Location
- China
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 29/09/2023 | 02/10/2023 | Yes | No |
Editorial Notes
08/01/2024: The following updates were made to the study record:
1. The recruitment end date was from 31/12/2023 to 31/03/2024.
2. The overall study end date was updated from 31/03/2024 to 30/06/2024.
3. The intention to publish date was updated from 31/12/2024 to 31/03/2025.
02/10/2023: Publication reference added.
30/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 31/12/2023.
2. The overall end date was changed from 31/07/2023 to 31/03/2024.
3. The plain English summary was updated to reflect these changes.
07/03/2023: The recruitment end date was changed from 28/02/2023 to 30/06/2023.
30/09/2021: Trial's existence confirmed by the Clinical Medical Research Ethics Committee of the First Affiliated Hospital, Anhui Medical University
