Acute exacerbation of idiopathic pulmonary fibrosis
Conditions
Interventions
High dose glucocorticoid control group:Methylprednisolone 160mg/qd intravenous for 3 days,then taped gradually.
Glucocorticoid impulse therapy group:Methylprednisolone 500mg/qd intravenous for 3 days
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Nanjing University Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age is between 50 and 80, both male and female; 2. The diagnosis of IPF is based on the 2018 International standard, with definite or probable IPF; 3. A definite or suspected AE diagnosis meets the following criteria and is eligible for AE-IPF to the exclusion of other diagnoses that lead to worsening acute respiratory conditions: (1) Previous or current diagnosis of IPF; (2) Acute exacerbation or progression of dyspnea, usually within 1 month; (3) Chest HRCT showed diffuse GGO and/or consolidation in bileral lungs on the background of UIP pattern, such as reticular or honeycombing; 4. Blood gas analysis indicated that the oxygenation index (PaO2/FiO2 ratio) <= 200; 5. Informed consent has been signed by the subject personally or a relative.
Exclusion criteria
Exclusion criteria: 1. Acute exacerbations caused by idiopathic nonspecific interstitial pneumonia (NSIF) and connective tissue (CTD) associated ILD and fibrotic hypersensitivity pneumonia were excluded; 2. Obvious pulmonary infection, pneumothorax, pulmonary embolism, left heart failure or fluid overload were excluded; 3. The subjects with active malignant tumor; 4. The subjects who have received endotracheal intubation and mechanical ventilation; 5. The patients have registered for lung transplantation; 6. Subjects enrolled in any other clinical trials before screening within 3 months; 7. Patients who are expected to die 14 days after starting medication because of other diseases; 8. Patients with severe hepatic and renal insufficiency, such as AST, ALT, total bilirubin (TB) or more than 1.5 times the upper limit of the normal range value, and serum creatinine clearance rate (Cr Cl) < 50 mL/min; 9. Patients wiht positive hepatitis B virus or carriers; 10. Patients who are allergic to corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 month survival rate;Chest HRCT scores;Variables of pulmonary function test;Biomarkers of pulmonary fibrosis;times of infection disease;Hypertension;Diabetes Mellitus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;PaO2/FiO2;Borg dysnea and cough Scores;Stay in hospital (days);Time of off the ventilator (days); | — |
Countries
China
Contacts
Public ContactMengshu Cao
Nanjing Drum Tower Hospital, The Affiliated Nanjing University Medical School
Outcome results
None listed