Interstitial Lung Disease Trial, Completed NCT04525547 Sponsor: Boehringer Ingelheim Condition: Interstitial Lung Disease
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT04525547) enrolled 70 participants, all of whom received the treatment being studied — a medication called Ofev (nintedanib). Of those 70 people, 65 completed the trial and 5 did not. The trial was measuring two main things: how many participants experienced adverse events (unwanted health events recorded during the study), and how a lung function measurement called Forced Vital Capacity (FVC) changed over time. FVC is simply a measure of how much air a person can forcefully breathe out in one go, recorded in millilitres (mL). The reported data shows that 36 out of 70 participants experienced at least one adverse event while taking Ofev. Regarding lung function, the reported data shows that the average FVC measurement changed by minus 15 mL after 12 weeks of treatment compared to where participants started — meaning, on average, the group's FVC was slightly lower than at the beginning. After 24 weeks, the reported average change was minus 44 mL compared to the starting point. The trial did not appear to include a comparison group (such as a placebo group), so these numbers reflect only the single group of participants who took Ofev. No secondary outcome measure data was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Interstitial Lung Disease Trial, Completed

NCT04525547
Completed Not Applicable

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 have been prescribed and started on a medication called Ofev (nintedanib), following the approved guidelines for its use in Korea
  • You have signed a form giving permission for your data to be used in the study

Who may not be able to join:

  • You are not able to take nintedanib (Ofev) for medical reasons based on the official guidelines in Korea
  • You have a known allergy or sensitivity to Ofev, peanuts, soya, or any of the ingredients in the medication
  • You are currently pregnant or breastfeeding
  • You have moderate or severe liver problems (confirm with trial site)

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
13 January 2021
Est. completion
2 August 2022

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Number of Patients With Adverse Events Who Took at Least One Dose of Ofev; Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment; Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment

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