A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
This study is a randomized, double-blind, placebo-controlled, multicenter clinical study. The main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.
• 1\. Age 18\
‣ 70 years old (including 18 years old and 70 years old), gender is not limited.
• 2\. Diagnosed with silicosis or coal worker's pneumoconiosis, in line with GBZ 70-2015 Diagnosis of Occupational Pneumoconiosis.
• 3\. Forced vital capacity at screening percentage of predicted value %FVC≥40% and \<80% 4. The percentage of carbon monoxide dispersion in the predicted value at the time of screening %DLCO≥30% and \<80%.
⁃ HRCT at screening showed diffuse interstitial changes in the lungs. 6. Patients voluntarily participated in this trial, with good compliance, and had the ability to understand and sign informed consent before the study.