Recruiting

Pirfenidone Capsules for Pneumoconiosis

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Study Aim

This study aims to evaluate the effectiveness of Pirfenidone capsules in improving lung function over a year in individuals with pneumoconiosis.

What is being tested

Pirfenidone Capsules

+ placebo capsules

Drug
Who is being recruted

Lung Diseases+3

+ Occupational Diseases

+ Pneumoconiosis

From 18 to 70 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorBeijing Continent Pharmaceutical Co, Ltd.
Study ContactLing Zhang, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 7, 2022

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a medication called Pirfenidone for treating pneumoconiosis, a lung disease caused by inhaling dust particles. A total of 272 individuals diagnosed with pneumoconiosis are participating in this study. The primary goal is to determine if Pirfenidone can improve lung function and slow down the disease progression. By finding an effective treatment, this study aims to enhance the quality of life for those suffering from this condition. Participants in the study are divided into two groups. One group receives Pirfenidone capsules, while the other group receives a placebo, which is a substance with no active drug. This setup helps researchers determine the true effect of the medication. The study lasts for 52 weeks, and during this time, changes in lung function are closely monitored by measuring the forced vital capacity (FVC) percentage, which indicates how much air the lungs can hold. The results will show whether Pirfenidone provides a significant benefit compared to the placebo.

Official TitleA Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
NCT05288179
Principal SponsorBeijing Continent Pharmaceutical Co, Ltd.
Study ContactLing Zhang, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

272 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesOccupational DiseasesPneumoconiosisRespiratory Tract DiseasesLung Diseases, InterstitialLung Injury

Criteria

6 inclusion criteria required to participate
Age 18\~70 years old (including 18 years old and 70 years old), gender is not limited.
Diagnosed with silicosis or coal worker's pneumoconiosis, in line with GBZ 70-2015 "Diagnosis of Occupational Pneumoconiosis".
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%.
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26 exclusion criteria prevent from participating
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.
ALT or AST \> 3 times ULN.
Patients with dysphagia or clinical signs of malabsorption or who require parenteral nutrition.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patient takes pirfenidone 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time

Group II

Placebo
Patients take a placebo 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Beijing China-Japan Friendship Hospital

Beijing, ChinaOpen Beijing China-Japan Friendship Hospital in Google Maps
Recruiting
One Study Center