Phase 3 Interstitial Lung Disease Trial, Recruiting NCT05288179 Sponsor: Beijing Continent Pharmaceutical Co, Ltd. Condition: Interstitial Lung Disease
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Phase 3 Interstitial Lung Disease Trial, Recruiting

NCT05288179
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 70 years old (both ages included), and any gender may apply
  • You have been officially diagnosed with silicosis or coal worker's pneumoconiosis according to Chinese occupational disease diagnostic standards
  • Your lung breathing capacity (FVC) is between 40% and 80% of what would be expected for a healthy person your age
  • Your lungs' ability to transfer oxygen into the blood (DLCO) is between 30% and 80% of the expected normal level
  • A special type of chest scan (HRCT) shows widespread changes to the tissue throughout your lungs
  • You are willing to take part, can follow the study instructions, and are able to read and sign a consent form

Who may not be able to join:

  • You have had a lung wash-out procedure (lung lavage) in the last 3 months, or plan to have one during the trial
  • Your liver function blood test results are significantly higher than normal (confirm with trial site)
  • Your kidney function is significantly reduced (confirm with trial site)
  • You have had an infection or high fever in the past 4 weeks, such as chest infection, pneumonia, sinus infection, urinary tract infection, or a skin infection
  • You currently have tuberculosis or lung cancer
  • You have serious high blood pressure in the lungs or severe right-sided heart failure that your doctor feels makes participation unsafe
  • You have had serious heart or blood pressure problems, including very high uncontrolled blood pressure in the last 6 weeks, a heart attack in the last 6 months, or unstable chest pain in the last 6 months
  • Your blood clotting test results are significantly above normal (confirm with trial site)
  • You have difficulty swallowing, problems absorbing food, or need to be fed through a tube or drip
  • You have an active stomach ulcer
  • You have had a blood clot, stroke, or mini-stroke in the last 12 months
  • You are currently taking certain immune-suppressing or cell-affecting medications, such as methotrexate, cyclosporine, or TNF-alpha inhibitors (confirm with trial site for full list)
  • You have taken certain specific lung or related medications within the last month before joining, including nintedanib or high-dose acetylcysteine (confirm with trial site for full list)
  • You have previously taken medications that can cause lung scarring (such as amiodarone), or have been exposed to asbestos, beryllium, or radiation
  • You are allergic to the study drug or any of its ingredients (including lactose)
  • Your doctor believes you have less than 2.5 years to live due to another medical condition
  • You have a major operation planned during the time you would be on the trial
  • You are pregnant, breastfeeding, or planning to become pregnant during the trial
  • You are a woman who could become pregnant but are unwilling or unable to use reliable contraception from 28 days before to 3 months after taking the study drug
  • Your doctor believes you have a problem with alcohol or drug misuse
  • You have a mental illness
  • You have taken part in another clinical drug trial in the last 3 months
  • For any other reason, the trial doctor does not think it is safe or suitable for you to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Huaping Dai, Dr, China-Japan Friendship Hospital

Phone: 13501209210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Beijing Continent Pharmaceutical Co, Ltd.
Registry
ClinicalTrials.gov
Start date
7 June 2022
Est. completion
30 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Changes in pulmonary function FVC%

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov