A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Inclusion Criteria:
1. Written informed consent signed;
2. 18-75 years of age;
3. Clinically or multidisciplinarily diagnosed idiopathic pulmonary fibrosis(see 2011
guidance );
4. Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal
predicted value.
Exclusion Criteria:
1. Allergic to pirfenidone;
2. Dyspnea symptoms relieved in the past 6 months;
3. Patients in acute exacerbation phase;
4. Diabetic patients whose fasting venous glucose >11.1 mmol/L;
5. Patients with malignant tumor and hemorrhagic diseases;
6. Patients with serious underlying pulmonary disease;
7. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times
above the upper level of normal value range), kidney disease(Cr above the upper level
of normal value range);
8. Patients who has taken Acetylcysteine in the past 3 months;
9. Patients who has taken Prednisone>15mg/day(or other equivalent amount of
glucocorticoid) and/or Immunosuppresants in the past 3 months;
10. Patients who has taken interferon, penicillamine, colchine or other agents for the
treatment of IPF;
11. Pregnant or lactating women;
12. Participated in other clinical trials in the past 1 month;
13. The investigator assessed as inappropriate to participate in this clinical trial.