Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease
Conditions
Interventions
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 c
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of clinical symptoms is measured using the EXACT-PRO score at the end of treatment on day 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed