Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
NCT ID: NCT05288179
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
272 participants
INTERVENTIONAL
2022-06-07
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
NCT00287729
Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
NCT02136992
Pirfenidone in Adult Hospitalized Patients With COVID-19
NCT05713292
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
NCT00287716
Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)
NCT01504334
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pirfenidone group
Patient takes pirfenidone 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
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
placebo group
Patients take a placebo 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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% 4. 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. 6. Patients voluntarily participated in this trial, with good compliance, and had the ability to understand and sign informed consent before the study.
3\. 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.
7\. 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.
9\. Severe cardiovascular disease with one of the following conditions:
1. Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);
2. Myocardial infarction within 6 months;
3. Unstable angina within 6 months. 10. Coagulation parameters: International normalized ratio (INR) \> 2, prothrombin time (PT) prolongation \> 1.5 times ULN.
11\. 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.
12\. Patients with dysphagia or clinical signs of malabsorption or who require parenteral nutrition.
13\. With active peptic ulcer. 14. History of thrombotic events (including stroke and transient ischemic attack) within 12 months.
15\. 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.
16\. 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.
17\. 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.
18\. Hypersensitivity to the investigational drug or its components (eg, lactose).
19\. Investigator judges that life expectancy due to other medical conditions is \< 2.5 years.
20\. Major surgery planned during treatment. 21. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial.
22\. Women of childbearing age who are unwilling or unable to use a highly effective method of contraception during the 28 days before or 3 months after dosing.
23\. According to the researcher, the patient is either alcohol or drug abuser. 24. mentally ill. 25. Those who participated in clinical trials of other drugs within 3 months. 26. Investigators judged to be unfit to participate in the trial.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Continent Pharmaceutical Co, Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huaping Dai, Dr
Role: PRINCIPAL_INVESTIGATOR
China-Japan Friendship Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing China-Japan Friendship Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GNI-F647-202101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.