Phase 4 Interstitial Lung Disease Trial, Recruiting NCT06479603 Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Condition: Interstitial Lung Disease
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Phase 4 Interstitial Lung Disease Trial, Recruiting

NCT06479603
Recruiting Phase 4

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:

  • People who are older than 18 years of age
  • People who have been diagnosed with pulmonary sarcoidosis — either confirmed through imaging and tissue samples showing a specific type of inflammation (with no other known cause), or in some cases confirmed through a specialist team discussion when tissue sampling was not possible (confirm with trial site)
  • People whose CT scan shows signs of scarring affecting 20% or more of the lungs, such as thickening, irregular lines, or other structural changes
  • People who have had shortness of breath during activity or persistent cough lasting more than 3 months
  • People whose lung function test results fall below 80% of what would normally be expected for their age and sex, or who experience a significant drop in oxygen levels during a 6-minute walking test
  • People who have been taking stable doses of immune-suppressing medications (such as steroids alone, or combined with methotrexate, azathioprine, or mycophenolate mofetil) for more than 3 months

Who may not be able to join:

  • People who have another heart or lung condition, or other serious illness, that could better explain their symptoms (with an exception for a specific type of high blood pressure in the lungs related to sarcoidosis scarring)
  • People who have a known allergy or medical reason to avoid the study drug nintedanib, including those on high-dose blood thinners or those with bleeding disorders
  • People who have taken anti-scarring medications such as pirfenidone or nintedanib for 8 weeks or more in the past year
  • People whose liver function blood tests are significantly abnormal at the start of the trial (with a noted exception for a condition called Gilbert's syndrome — confirm with trial site)
  • People whose kidney function blood test (creatinine) is above a certain level
  • People with uncontrolled heart failure
  • People with another serious illness such as cancer, a chronic debilitating condition, or a history of drug abuse
  • People who are pregnant or breastfeeding
  • People who do not wish to take part in the study

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Registry
ClinicalTrials.gov
Start date
30 June 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇮🇳 India

Primary endpoints

The difference in the mean change in forced vital capacity (FVC) between the study groups

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: 28 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