NCT05288179

Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Pneumoconiosis

Interventions

Type	Name	Description
DRUG	Pirfenidone Capsules	After randomization, the experimental group took pirfenidone capsules 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
DRUG	placebo capsules	After randomization, the experimental group took placebo capsules 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time

Timeline

• Start date: 2022-06-07
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2022-03-21
• Last updated: 2025-11-24

Locations

1 site across 1 country: China