Nintedanib for Interstitial Lung Disease
(MINT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nintedanib, a drug that slows lung damage, in patients with myositis-associated interstitial lung disease. It works by blocking proteins that cause lung inflammation and scarring. Nintedanib has been approved for treating certain lung diseases and has shown positive results in various conditions.
Will I have to stop taking my current medications?
The trial allows participants to continue certain medications, specifically up to two immunosuppressive drugs or one glucocorticoid and one immunosuppressive drug, as long as they have been stable for a specified period before the trial. However, some medications like cyclophosphamide and certain biological agents must be stopped before the trial. Please consult with the trial team for specific guidance on your medications.
Is Nintedanib safe for humans?
How is the drug Nintedanib unique for treating interstitial lung disease?
Nintedanib is unique because it is an oral medication that targets multiple pathways involved in fibrosis (scarring of lung tissue), and it has been shown to slow the progression of interstitial lung disease by reducing lung function decline. It is particularly notable for its use in conditions like idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease, where it helps manage disease progression.678910
What data supports the effectiveness of the drug Nintedanib for Interstitial Lung Disease?
Research shows that Nintedanib can slow the progression of lung diseases like idiopathic pulmonary fibrosis (IPF) by reducing the decline in lung function. It has also been effective in patients with progressive fibrosing interstitial lung diseases, helping to maintain lung capacity over time.5781112
Who Is on the Research Team?
Rohit Aggarwal, MD, MS
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for people living in the U.S. who have myositis-associated interstitial lung disease, can speak English or Spanish, and haven't used OFEV for treatment. It's not for those needing high levels of oxygen (10L+), planning major surgery within 6 months, undergoing evaluation or past recipients of a lung transplant, or women who are pregnant/lactating or planning pregnancy soon.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo or nintedanib plus standard of care for 12 weeks, followed by open-label nintedanib for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nintedanib
- Placebo
- Standard of Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rohit Aggarwal, MD
Lead Sponsor
Boehringer Ingelheim
Industry Sponsor