Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

NCT05288179 | Recruiting Phase 3

• 1 other identifier: GNI-F647-202101
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in pulmonary function FVC%

  Change in FVC % (FVC % predicted) at 52 weeks of treatment

  52 weeks

Secondary Outcomes (2)

• Pulmonary function FVC

  52 weeks

• Changes in lung function DLco%

  52 weeks

Study Arms (2)

Pirfenidone group

EXPERIMENTAL

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

Drug: Pirfenidone Capsules

placebo group

PLACEBO COMPARATOR

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

Drug: placebo capsules

Interventions

Pirfenidone Capsules DRUG

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

Also known as: F647

Pirfenidone group

placebo capsules DRUG

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

Also known as: N

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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% 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.

You may not qualify if:

• \. ALT or AST \> 3 times ULN. 4. TBiL \> 2 times ULN. 5. Creatinine clearance \<30 mL/min. 6. 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.
• \. Combined with tuberculosis or lung cancer. 8. 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.
• \. Severe cardiovascular disease with one of the following conditions:
• Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);
• Myocardial infarction within 6 months;
• Unstable angina within 6 months. 10. Coagulation parameters: International normalized ratio (INR) \> 2, prothrombin time (PT) prolongation \> 1.5 times ULN.
• \. Other conditions or comorbidities that may interfere with testing procedures (eg, intolerance to interruption of supplemental oxygen during pulmonary function tests) or, based on the investigator's judgment, that may interfere with trial participation or that may put patients at risk.
• \. Patients with dysphagia or clinical signs of malabsorption or who require parenteral nutrition.
• \. With active peptic ulcer. 14. History of thrombotic events (including stroke and transient ischemic attack) within 12 months.
• \. Use of cytotoxic drugs, immunosuppressive drugs, cytokine-modulating drugs, or receptor antagonist drugs such as azathioprine, cyclophosphamide, cyclosporine, etanercept, infliximab, white Triene antagonists, methotrexate, tacrolimus, TNF-α inhibitors and tyrosine kinase inhibitors TKIs and other drugs.
• \. Use of interferon, bisbenzylisoquinoline alkaloids (tetrandrine), polyethylene pyrimidine nitroxide (gramsilpine), quinape phosphate, hydroxyquinoline phosphate, aluminum citrate within 1 month before randomization , nintedanib, or high-dose acetylcysteine.
• \. Patients who have previously used drugs that may cause pulmonary fibrosis, such as amiodarone, or have been exposed to asbestos, beryllium and other substances, or exposed to radioactive environments.
• \. Hypersensitivity to the investigational drug or its components (eg, lactose).
• \. Investigator judges that life expectancy due to other medical conditions is \< 2.5 years.
• \. Major surgery planned during treatment. 21. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (1)

Beijing China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pneumoconiosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• Huaping Dai, Dr

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhang, Dr

CONTACT

13501209210; zhangling@bjcontinent.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 21, 2022
• Study Start: June 7, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)