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 sites300 target enrollmentOctober 7, 2021

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37775286/ (added 02/10/2023)

Registry

who.int

Start Date

October 7, 2021

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Beijing University of Chinese Medicine

•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.

•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).