ISRCTN99049821进行中（未招募）未知
A multicentre, randomised, double-blind, controlled trial to evaluate the efficacy and safety of Shufeng Jiedu capsule in acute exacerbation of COPD
Beijing University of Chinese Medicine0 个研究点目标入组 300 人开始时间: 2021年10月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37775286/ (added 02/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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).
研究者
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