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Tyrosine Kinase Inhibitor
Nintedanib for Interstitial Lung Disease
Phase 3
Waitlist Available
Led By Rahul Sangani, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease (PF-CMD- ILD) based on a history of at least 5 years' work in surface or underground coal mining and presence of Progressive Massive Fibrosis (PMF) within 24 months of screening visit; or small opacity pneumoconiosis plus decline in percent predicted FVC of > 10% relative to high quality spirometry performed 12-24 months prior to screening visit, as assessed by the investigator
Male or female patients aged >= 18 years at Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Study Summary
This trial is testing whether nintedanib is a safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks.
Who is the study for?
This trial is for adults over 18 with progressive fibrosing lung disease from coal dust, who have worked in coal mining for at least 5 years. They must have a certain level of lung and breathing function and not be currently exposed to coal dust. People can't join if they've used nintedanib before, have severe liver disease, recent cardiovascular issues, peanut allergy, or are pregnant or unwilling to use birth control.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Nintedanib compared to a placebo in slowing down lung function decline over one year. Participants will take either Nintedanib or a placebo twice daily. The groups are balanced by smoking history and type of lung disease.See study design
What are the potential side effects?
Nintedanib may cause side effects like diarrhea, nausea, abdominal pain, liver enzyme elevation which could indicate liver damage, bleeding risk increase due to its effect on blood clotting factors; however specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lung disease from working in coal mines for over 5 years and it's getting worse.
Select...
I am 18 years old or older.
Select...
My chest scan shows signs of severe lung disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annual rate of decline in FVC in mL (absolute)
Secondary outcome measures
6 Minute Walk Test
Absolute FEV1 annual rate of decline in mL
Lung Diseases, Interstitial
+15 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: NintedanibActive Control1 Intervention
Nintedanib 150 mg administered PO twice daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered PO twice daily
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
175 Previous Clinical Trials
56,146 Total Patients Enrolled
Rahul Sangani, MDPrincipal InvestigatorWest Virginia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that the amount of oxygen your lungs can transfer to your blood is too low or too high.I have not experienced any significant medical events in the last 3 months.I am not pregnant, nursing, or planning to become pregnant during the trial.I have mild liver disease and can start treatment with a specific dose.My doctor thinks I have more than 2.5 years to live, not counting my lung condition.My lung function has been stable over the past year, with less than a 10% decrease.I have been treated with nintedanib or pirfenidone.I have a heart condition.I am scheduled for a major surgery soon.I haven't taken any experimental drugs in the last month or longer.I have lung disease from working in coal mines for over 5 years and it's getting worse.I am taking specific medications for lung disease or rheumatoid arthritis.I am using or willing to use effective birth control and a barrier method if I can have children.You are allergic to the trial medication or any of its ingredients, like soya lecithin.I am 18 years old or older.My chest scan shows signs of severe lung disease.I work in a job where I'm exposed to coal or silica dust.I am at risk of bleeding.You have an allergy to peanuts.Your bilirubin level is higher than 1.5 times the normal limit.My kidney function is low, with a creatinine clearance under 30 mL/min.You have another health condition that might affect the tests or could make it risky for you to take part in the trial.I have been diagnosed with severe PAH.Your lung function is at least 45% of what is expected for someone your age and size.I have been diagnosed with IPF according to the 2011 guidelines.Your liver enzyme levels are more than 1.5 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Nintedanib
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other studies like this been attempted before?
"Nintedanib is being trialed in 22 different studies, located in 53 cities across 30 countries. The first study, sponsored by Boehringer Ingelheim, occurred in 2012 and involved 140 patients. That trial completed its Phase 1 & 2 drug approval stage. Since then, 18320 studies have been completed."
Answered by AI
Are there any know side effects of Nintedanib?
"Nintedanib has shown efficacy in Phase 3 trials and has been backed by multiple rounds of safety data, so our team at Power rates its safety as a 3."
Answered by AI
For what purpose is Nintedanib most often taken by patients?
"Nintedanib is most often used to treat adenocarcinoma, but it can also help patients with conditions like metastatic non-small cell lung cancer, pharmacotherapy, and systemic scleroderma."
Answered by AI
Are there any similar medical studies that have used Nintedanib?
"At this time, there are a total of 22 clinical trials studying the effects of Nintedanib. 5 of these studies have reached Phase 3. Many of these studies originates from Chicago, Illinois, however there are 281 research sites globally."
Answered by AI
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