Idiopathic Pulmonary Fibrosis is a type of chronic lung disease that primarily causes degeneration of lung function. Common symptoms include an unshakable dry cough and constant shortness of breath. About 5 million people worldwide suffer from this lung disease.
Do you have idiopathic pulmonary fibrosis (IPF)?
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 40-80 years of age when signing consent and entering screening.
- Have been diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
- Are either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
- Weigh more than 40 kg (88 lb) at screening.
- Are a woman who can become pregnant:
- Are willing to use an approved birth control method during treatment and for at least 3 months after the last study dose.
- Are willing to not donate sperm during treatment and for at least 3 months after the last study dose.
- Are willing to follow all study rules and restrictions.
- Are willing and able to attend study visits and complete study procedures.
- Are able to perform spirometry (lung function testing) as required by the study.
You may not qualify to participate in this study if you:
- Have a lung disease caused by something other than IPF.
- Have a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
- Have another condition that significantly affects breathing.
- Have serious heart or blood vessel disease.
- Have had a recent or current infection.
- Have been recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
- Have a history of asthma (except childhood asthma that has resolved).
- Have another medical condition or abnormal test result that may affect study participation or safety.
- Cannot perform high-quality spirometry testing.
- Have obstructive lung disease.
- Have abnormal liver function tests.
- Have moderate to severe liver disease.
- Have severe kidney disease.
- Have recently used high-dose steroids or other immune-suppressing medications.
- Have active cancer or recent cancer treatment.
- Are on, or expected to be added to, a transplant list.
- Have had major surgery recently or has planned procedures that could interfere with the study.
- Have had a severe reaction to nintedanib or cannot take nintedanib safely.
- Have recently used certain medications that may interact with the study drug.
- Are currently using, or plans to use, prohibited medications during the study.
- Have recently participated in another clinical trial.
- Have current alcohol or drug abuse issues.
- Have donated a significant amount of blood recently.
- Have received a live vaccine recently.
- Currently smoke, recently smoked, or quit smoking less than 1 year ago.
- Require more than 6 L/min of oxygen while at rest.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
