COPD with respiratory failure
Conditions
Interventions
Intervention Group:The daily dose (4.8 mg/kg) is diluted in 48 mL of normal saline and continuously administered by intravenous infusion over 24 hours at a rate of 2 mL/h (equivalent to 0.2 mg/kg/h).
Control group:An equal volume of placebo, containing only the excipients of sodium sivelestat, was diluted to 48?ml and administered as a continuous intravenous infusion at a rate of 2?ml/hour over 24
Sponsors
Zhangzhou Hospital in Fujian Province
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, any gender; 2. Diagnosed with chronic obstructive pulmonary disease (COPD) according to the definition of the 'Guideline for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease in China (Revised Edition 2021)', with any symptom of cough, sputum production, or shortness of breath worsening within 2 weeks; 3. Acute exacerbation time < 72 hours; 4. Before undergoing respiratory support treatment, arterial blood gas analysis shows PO2 < 60 mmHg or oxygenation index < 200 mmHg without oxygen supplementation prior to randomization; 5. Voluntarily participate in the clinical study and sign a consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other respiratory system or respiratory system-related diseases, including but not limited to asthma, active tuberculosis, lung malignancies, interstitial lung diseases, clinically significant bronchiectasis, pneumoconiosis, pneumothorax, pleural effusion, hemoptysis or other active pulmonary diseases; 2. Known cardiovascular system diseases: including but not limited to unstable ischemic heart disease, New York Heart Association (NYHA) class III/IV, left heart failure, acute myocardial infarction; 3. Uncontrolled hypertension (resting sitting systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg during screening); 4. Neurological/psychiatric system disorders: mental or neurological functional abnormalities, unable to express will; 5. Diagnosed with malignant tumors within 5 years before randomization (excluding malignant tumors with low metastasis and mortality risks, such as adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ); 6. Abnormalities in electrocardiogram that require clinical intervention (atrial fibrillation, ventricular tachycardia, third-degree atrioventricular block, etc.) or prolonged QT interval (QTcF > 450 ms); 7. Abnormal laboratory tests before randomization: 8. Alanine aminotransferase (ALT) > 3×ULN (upper limit of normal); 9. Aspartate aminotransferase (AST) > 3×ULN; 10. Total bilirubin (TBIL) > 1.5×ULN; 11. Prothrombin time (PT) > ULN + 3s; 12. Creatinine (Cr) > 1.5×ULN; or estimated glomerular filtration rate = 1×10^3 IU [or copies] /mL), or positive hepatitis C antibody, or positive human immunodeficiency virus (HIV), or positive Treponema pallidum antibody; 14. Known or suspected allergy to sivelestat sodium or its components; 15. Participation in other clinical studies and use of investigational drugs containing active ingredients within 4 weeks before screening, or still within 5 half-lives of the investigational drug at the time of screening (whichever is longer); 16. Lactating women or those with positive pregnancy test results, or women planning to become pregnant during the study; 17. History of drug abuse or alcoholism (average weekly alcohol consumption >= 14 units: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) within 1 year before screening; 18. Long-term use of glucocorticoids > 3 weeks before admission; 19. Expected survival < 48 hours; 20. Patients with concurrent pneumothorax and pulmonary embolism; 21. Other medical or social reasons that the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve by >=2 levels on the 7-point orderly scale recommended by the World Health Organization.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tracheal intubation rate;28 days without ventilator support (VFD);ICU hospitalization duration;Improvement in oxygenation within 28 days;Total hospitalization time; | — |
Countries
China
Contacts
Public ContactLin Li
Zhangzhou Hospital in Fujian Province
Outcome results
None listed