PneumoconiosisPhase 3NCT05288179
Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
A Phase 3 study testing Pirfenidone Capsules in people with Pneumoconiosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumoconiosis
- What is being tested?
- Pirfenidone Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2022to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);
- Myocardial infarction within 6 months;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing China-Japan Friendship Hospital
Beijing
Huaiping Dai, daihuaping@sina.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
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.
Read the detailed description
272 patients with pneumoconiosis participated in the 52-week study and were randomized to pirfenidone or placebo.
- Conditions
- Pneumoconiosis
- Being tested
- Pirfenidone Capsules, placebo capsules
- Medical subject headings
- Pneumoconiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone CapsulesDrug
Also called F647
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 capsulesDrug
Also called N
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulmonary function FVC%
Change in FVC % (FVC % predicted) at 52 weeks of treatment
Measured: 52 weeks
Secondary outcomes (2)
Pulmonary function FVC
Changes in FVC (L) at 52 weeks of treatment
Measured: 52 weeks
Changes in lung function DLco%
Change in DLco% at 52 weeks of treatment
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start7 Jun 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoconiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huaping Dai, Dr, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288179
- Sponsor's protocol ID
- GNI-F647-202101
- Status last verified
- Nov 2025
- First submitted
- 17 Feb 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
- ClinicalTrials.gov ID
- NCT05288179
- Acronym / sponsor ID
- GNI-F647-202101
- Conditions
- Pneumoconiosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
272 patients with pneumoconiosis participated in the 52-week study and were randomized to pirfenidone or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone group | Experimental | Drug: Pirfenidone CapsulesPatient takes pirfenidone 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time |
| placebo group | Placebo comparator | Drug: placebo capsulesPatients take a placebo 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone CapsulesAlso: F647After 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 | Pirfenidone group |
| placebo capsulesAlso: NAfter 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 | Drug | placebo group |
Primary outcome
Changes in pulmonary function FVC%
Time frame: 52 weeks
Change in FVC % (FVC % predicted) at 52 weeks of treatment
2 secondary outcomes
Pulmonary function FVC
Time frame: 52 weeks
Changes in lung function DLco%
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaping Dai, Dr principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone Capsules in people with Pneumoconiosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhang, Dr (13501209210 ext. +86, zhangling@bjcontinent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulmonary function FVC% (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.