← Back to Search

Tyrosine Kinase Inhibitor

Nintedanib for Interstitial Lung Disease

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first nintedanib intake until last nintedanib intake + 28 days of residual effect period (rep), up to 1195 days.
Awards & highlights

Study Summary

This study is evaluating whether a drug called nintedanib is safe and tolerable for people with idiopathic pulmonary fibrosis.

Eligible Conditions
  • Interstitial Lung Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first nintedanib intake until last nintedanib intake + 28 days of residual effect period (rep), up to 1195 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first nintedanib intake until last nintedanib intake + 28 days of residual effect period (rep), up to 1195 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Any Adverse Events

Side effects data

From 2017 Phase 4 trial • 105 Patients • NCT02579603
31%
Diarrhoea
16%
Dyspnoea
12%
Vomiting
12%
Nausea
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Dizziness
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Gastrooesophageal reflux disease
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone

Trial Design

1Treatment groups
Experimental Treatment
Group I: NintedanibExperimental Treatment1 Intervention
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
2015
Completed Phase 4
~3680

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,502 Previous Clinical Trials
11,339,511 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Rhode Island
How old are they?
65+
What site did they apply to?
A.O.U. Policlinico Vittorio Emanuele
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
2019. "A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03820726.
~72 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top