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Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

NCT05288179 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Pneumoconiosis

Interventions

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

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Principal Investigators

  • Huaping Dai, Dr · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288179 on ClinicalTrials.gov