Can a lung fibrosis drug help miners breathe easier?
NCT ID NCT05288179
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether pirfenidone capsules can improve lung function in 272 people with pneumoconiosis, a lung disease caused by inhaling dust. Participants take the drug or a placebo three times daily for a year. The main goal is to see if lung function (measured by FVC) improves or stabilizes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pirfenidone capsules
- What this could lead to
- If it works, this could provide a treatment option to slow lung function decline in people with pneumoconiosis.
- What could go wrong
- This is a Phase 3 trial, but pneumoconiosis is a chronic, progressive disease and pirfenidone may not reverse damage. Side effects like nausea and rash are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 272 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age 18\~70 years old (including 18 years old and 70 years old), gender is not limited. 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. Exclusion Criteria: * 1\. Those who do not meet any of the inclusion criteria. 2. Those who have received lung lavage therapy within 3 months and plan to receive lung lavage therapy during the trial. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing China-Japan Friendship Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.