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NCT02999178 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 663
- Enrollment target
NCT02999178: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02999178 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 663 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02999178, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 663 participants
- Enrollment target
Study Summary
The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of \>10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.
Primary Outcome
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall population consists of all randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only or HRCT fibrotic pattern= Other fibrotic patterns. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in the overall population is based on a random coefficient regression with fixed effects for tr
Interventions
- DRUG Placebo
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 663 participants |
| Start Date | 2017-01-17 |
| Est. Completion | 2019-08-12 |
| Phase | Phase 3 |
What the finished NCT02999178 record still lists
NCT02999178 is an interventional study that assigns participants to a tested intervention. The registered 663 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02999178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02999178 about?
NCT02999178 is a clinical study titled "Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)". The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of \>10% extent on high-resolution computed tom...
What is the current status of trial NCT02999178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2017-01-17. Estimated completion is 2019-08-12.
What interventions are being tested in trial NCT02999178?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT02999178?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02999178's enrollment target sits among peer trials
663 553rd of 2000 higher than 1,447 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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