A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

Beijing Continent Pharmaceutical Co, Ltd.1 site in 1 country272 target enrollmentJune 7, 2022

Overview

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.

272 patients with pneumoconiosis participated in the 52-week study and were randomized to pirfenidone or placebo.

Registry

clinicaltrials.gov

Start Date

June 7, 2022

End Date

September 30, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Responsible Party

Sponsor

•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%
•The percentage of carbon monoxide dispersion in the predicted value at the time of screening %DLCO≥30% and \<80%.
•5.HRCT at screening showed diffuse interstitial changes in the lungs.
•Patients voluntarily participated in this trial, with good compliance, and had the ability to understand and sign informed consent before the study.

•1\. Those who do not meet any of the inclusion criteria.
•Those who have received lung lavage therapy within 3 months and plan to receive lung lavage therapy during the trial.
•3\. ALT or AST \> 3 times ULN.
•TBiL \> 2 times ULN.
•Creatinine clearance \<30 mL/min.
•Patients with co-infection or high fever within 4 weeks prior to screening, including but not limited to acute bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis.
•7\. Combined with tuberculosis or lung cancer.
•Significant pulmonary arterial hypertension requiring parenteral therapy with epoprostenol/treprostinil or severe right heart failure determined by the investigator to be unsuitable to participate in the trial.
•9\. Severe cardiovascular disease with one of the following conditions:
•Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);