Phase 3 Interstitial Lung Disease Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 40 years or older at the first study visit
• People who have been diagnosed with idiopathic pulmonary fibrosis (IPF) — a type of lung scarring disease — within the last 6 years before the first study visit, based on established international medical guidelines
• People whose lung scan (a type of detailed CT scan) results, and surgical lung biopsy results if available, are consistent with an IPF diagnosis, where the scan was taken within 18 months of the first study visit
• People whose lungs have a significantly reduced ability to absorb oxygen — specifically, a carbon monoxide diffusion test result at or below 35% of what would normally be expected — at the first study visit
• People who are able to provide written consent to participate before any study procedures begin

Who may not be able to join:

• People who have previously been enrolled in this same trial
• People whose liver enzyme levels (ALT or AST) are more than 1.5 times the upper limit of the normal range at the first study visit
• People whose total bilirubin (a substance related to liver function) is more than 1.5 times the upper limit of the normal range at the first study visit
• People who have a significant airway blockage, based on a specific breathing test result at the first study visit (confirm with trial site)
• People who have had a heart attack within 6 months before the first study visit, or unstable chest pain (angina) within 1 month before the first study visit
• People with a known genetic tendency to bleed easily
• People who need blood-thinning medicines at full therapeutic doses, or high-dose anti-clotting medicines such as warfarin, heparin, or similar treatments
• People who have had a bleeding event in the brain within 12 months before the first study visit
• People who have had coughing up of blood, blood in the urine, active stomach or intestinal bleeding or ulcers, or a major injury or surgery within 3 months before the first study visit
• People whose blood clotting test results (INR, PT, or aPTT) fall outside specified limits at the first study visit (confirm with trial site)
• People who have planned major surgery during the trial, including lung transplant or major abdominal or intestinal surgery
• People who have had a blood clot event — including stroke or a brief stroke-like episode — within 12 months before the first study visit
• People whose kidneys are not filtering blood well enough, based on a specific calculation at the first study visit (confirm with trial site)
• People with a narrowing of the aortic heart valve (aortic stenosis), as assessed by the treating doctor at the first study visit
• People with severe heart failure where the heart is pumping at less than 25% of its normal capacity, as assessed by the treating doctor
• People with a condition involving abnormal thickening of the heart muscle that obstructs blood flow (idiopathic hypertrophic subaortic stenosis), as assessed by the treating doctor
• People with certain types of irregular heart electrical signals (second- or third-degree heart block) seen on a heart tracing (ECG)
• People with low blood pressure — either resting low blood pressure or blood pressure that drops significantly when standing up — at the first study visit
• People with uncontrolled high blood pressure at the first study visit
• People with certain penile conditions or blood disorders that may increase the risk of a prolonged, painful erection (priapism)
• People with a hereditary eye condition called retinitis pigmentosa
• People with a history of vision loss
• People with a history of a specific type of eye condition affecting the optic nerve (non-arteritic ischemic optic neuropathy)
• People with a condition called veno-occlusive disease (a blockage affecting certain blood vessels)
• People who have had a sudden worsening of their IPF, or a respiratory infection, within 8 weeks before the second study visit
• People who have taken certain medications within 4 weeks before the second study visit, including nitrates, N-acetylcysteine, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, high-dose steroids, or any other experimental drug
• People who have taken certain medicines that affect blood vessel function — including prostaglandins, endothelin-1 antagonists, phosphodiesterase inhibitors (such as sildenafil or tadalafil), or guanylate cyclase stimulators — within 4 weeks before the second study visit
• People who have taken strong CYP3A4 inhibitor medicines (such as ketoconazole, itraconazole, or ritonavir) within 4 weeks before the second study visit
• People who have taken L-arginine supplements or consumed grapefruit juice or St John's Wort within 4 weeks before the second study visit
• People who have taken a reduced dose of nintedanib (100 mg twice daily) within 4 weeks before the second study visit
• People who have previously stopped taking nintedanib permanently because of side effects that were considered to be caused by the drug
• People with a known allergy or intolerance to nintedanib, sildenafil, galactose, peanuts, soy, or any other components of the study medications
• People with any other condition or illness that the treating doctor believes could interfere with the study or put the person at risk
• People with alcohol or drug use that the treating doctor believes would interfere with treatment
• Additional exclusion criteria may also apply (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.