acute exacerbations of chronic obstructive pulmonary disease
Conditions
Interventions
Intravenous hormone group:40mg sodium methylprednisolone succinate for injection (dissolved in 0.9% saline or 5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecut
Nebulized inhalation group:Nebulized inhalation group: 2 mg budesonide suspension for inhalation, nebulized inhalation for 30 minutes, administered 4 times a day for 5 consecutive days.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as COPD by doctors for at least one year (based on GOLD standard) who need hospitalization or emergency treatment in case of acute exacerbation; 2.40 years old<=80 years old; 3. The patients and their families are willing to participate in the clinical research and sign the informed consent form; 4. Patients with moderate to severe COPD whose FEV1/FVC ratio<=0.7 (inhaled bronchodilator), FEV1 percentage in predicted value = 30% and<80%; 5. The subjects need to take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Active tuberculosis; 2. Bronchiectasis; 3. Have definite infectious diseases; 4. PCT = 0.5ng/ml or CRP = 30mg/L; 5. There were clinically significant new ECG abnormalities at the time of screening or within the previous 6 months. According to the judgment of the investigator, this abnormality may affect the subject's participation in the study; 6. Currently, there are clinically significant lung diseases other than COPD, such as sarcoidosis, interstitial lung disease, bronchiectasis a- 1. Antitrypsin deficiency, or other confirmed lung diseases; 7. Diagnosed as pulmonary heart disease, right ventricular failure, or moderate to severe pulmonary hypertension; 8. Subjects with a history of kidney, liver, metabolism, nervous system, hematology, ophthalmology, respiratory system, gastrointestinal tract, cerebrovascular or other major medical diseases or disorders that may interfere with the study or may interfere with the treatment of the study as judged by the researcher. Specific examples include, but are not limited to, poorly controlled insulin dependent diabetes; 9. Unstable ischemic heart disease, including acute myocardial infarction, existed within 1 year before screening, or unstable angina pectoris existed within 6 months before screening or during screening; 10. Patients with arrhythmia, including paroxysmal (e.g. intermittent) atrial fibrillation, will be excluded from this study. Note: There is persistent atrial fibrillation (defined as continuous atrial fibrillation for at least 6 months) and heart rate control strategy (i.e., selective ß Receptor blocker, calcium channel blocker, pacemaker implantation, digoxin or ablation treatment) and the anticoagulation effect is maintained at a stable and appropriate level for at least 6 months can be considered for inclusion. Note: Subjects with isolated ventricular premature contractions (PVC) or atrial premature contractions (PAC) can be considered for inclusion; 11. Cardiomyopathy is defined as phase III-IV (New York Heart Association) heart failure, or other related cardiovascular diseases, which may bring risks or affect the study according to the judgment of the study; 12. History of human immunodeficiency virus (HIV) infection, or HIV 1/2 serological results at screening (visit 1A) were positive; 13. Subjects with active autoimmune diseases or undergoing immunosuppressive therapy to treat autoimmune diseases (such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis); 14. There are laboratory abnormalities of clinical significance during screening: for example, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2 times the upper limit of normal range (ULN).Creatinine is twice higher than the normal upper limit; 15. Have contraindications of other glucocorticoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation index;Arterial partial pressure of carbon dioxide;Arterial blood pH;Respiratory rate;mMRC;CAT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mechanical ventilation time;ICU hospital stay;Pulmonary rales;Lymphocyte count;Inspiratory time as a percentage of the respiratory cycle; | — |
Countries
China
Contacts
Public ContactDan Li
The First Hospital of Jilin University,
Outcome results
None listed