Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2025-11-24
272
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of pirfenidone capsules for treating pneumoconiosis, a lung condition caused by inhaling dust. This is a randomized, double-blind, placebo-controlled, multicenter clinical trial involving 272 patients with pneumoconiosis. The study aims to confirm if pirfenidone improves lung function compared to a placebo over one year. Participants are randomly assigned to one of two groups: one takes pirfenidone capsules, and the other takes placebo capsules. Both groups take their assigned capsules three times a day with gradually increasing doses starting from 2 capsules per dose in the first week, 4 capsules in the second week, and 6 capsules from week 3 through week 52. The treatment period lasts for 52 weeks. During the study, participants undergo lung function tests to measure forced vital capacity (FVC) and carbon monoxide diffusion capacity (DLCO) at the start and after 52 weeks. Researchers monitor changes in these lung function measures to assess the treatment effects. The trial includes safety assessments and requires participants to comply with study procedures over the full year of treatment.
CONDITIONS
Brief Title
Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, any gender
- Diagnosed with silicosis or coal worker's pneumoconiosis according to GBZ 70-2015 criteria
- Forced vital capacity (FVC) percentage predicted between 40% and less than 80% at screening
- Carbon monoxide diffusion capacity (DLCO) percentage predicted between 30% and less than 80% at screening
- High-resolution CT scan showing diffuse interstitial lung changes at screening
- Voluntary participation with good compliance and ability to understand and sign informed consent
You will not qualify if you...
- Not meeting any inclusion criteria
- Received lung lavage therapy within 3 months or planning lung lavage during the trial
- Liver enzymes ALT or AST more than 3 times the upper limit of normal
- Total bilirubin more than 2 times the upper limit of normal
- Creatinine clearance less than 30 mL/min
- Recent infection or high fever in the last 4 weeks
- Having tuberculosis or lung cancer
- Significant pulmonary arterial hypertension requiring specific therapy or severe right heart failure
- Severe cardiovascular disease including recent uncontrolled hypertension, myocardial infarction, or unstable angina
- Coagulation abnormalities such as INR greater than 2 or prolonged prothrombin time
- Conditions interfering with testing procedures or trial participation
- Dysphagia, malabsorption, or need for parenteral nutrition
- Active peptic ulcer
- History of thrombotic events in the past 12 months
- Recent use of certain immunosuppressive, cytotoxic, or targeted drugs
- Recent use of drugs causing pulmonary fibrosis or exposure to harmful substances
- Hypersensitivity to study drug or components
- Life expectancy less than 2.5 years due to other conditions
- Planned major surgery during treatment
- Pregnant, breastfeeding, or planning pregnancy
- Women of childbearing potential unwilling or unable to use effective contraception
- Alcohol or drug abuse
- Mental illness
- Participation in other drug trials within 3 months
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants take pirfenidone or placebo capsules three times a day with increasing dose over the first two weeks, then a steady dose until Week 52.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Beijing China-Japan Friendship Hospital
Beijing, China
Actively Recruiting
Research Team
L
Ling Zhang, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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