Phase 2 Interstitial Lung Disease Trial, Recruiting

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, of any sex.
• People who are willing and able to sign a written consent form.
• People who have been diagnosed with IPF (idiopathic pulmonary fibrosis) within the last 5 years, confirmed by a specific type of chest scan (called an HRCT), where the scarring affects at least 10% of the lung and more than any emphysema present.
• People whose lungs can hold at least 45% of the expected air volume for someone their age and size (measured by a breathing test called FVC).
• People whose lungs can transfer enough oxygen into the blood — at least 30% of the expected level — based on a breathing test taken within 8 weeks before joining the trial.
• People currently taking nintedanib, pirfenidone, or nerandomilast (where that medicine has been approved) for IPF, who have been on a stable dose of that medicine for at least 12 weeks before joining.
• People who previously took nintedanib, pirfenidone, or nerandomilast but stopped taking it at least 8 weeks before joining.
• People who are able to use the inhaler device provided in the trial on their own, as instructed.

Who may not be able to join:

• People whose breathing test results show a certain pattern that may suggest another lung condition (a ratio of FEV1/FVC below 0.7 at screening) (confirm with trial site).
• People who have used N-acetyl cysteine or certain supplements — including quercetin, omega-3 fatty acids, DHEA, polyphenols, or phytochemicals — within 7 days before joining, or who would need to use them during the first 24 weeks of the trial.
• People who have been taking steroid tablets or injections at doses higher than 10 mg per day of prednisone (or an equivalent amount of another steroid) within 28 days before joining.
• People who are currently smokers.
• People who have had a sudden worsening of their lung condition (a pulmonary exacerbation) within 3 months before the screening visit.
• People who have had a lung infection with fever requiring antibiotic treatment within 28 days before joining.
• People who are currently in another clinical trial or have taken an experimental medicine or used an experimental medical device within 28 days of their screening visit (or longer, depending on the medicine involved).
• People with significantly reduced kidney function, based on blood test results at screening.
• People with significant liver problems, based on specific blood and other test results at screening.
• People who have had cancer within the past 5 years, with the exception of certain limited skin cancers, early-stage cervical cancer confined to the surface, or prostate cancer.
• People with a serious ongoing medical or mental health condition that, in the trial doctor's judgement, could interfere with participation — or people whose life expectancy is estimated at less than 24 weeks.
• Women of childbearing potential who test positive for pregnancy.
• Women who are currently breastfeeding.
• Women of childbearing potential, and men whose partners could become pregnant, who do not agree to use an acceptable form of contraception throughout the trial and for at least 90 days after the last dose of the study medicine. Male participants who do not agree to avoid donating sperm during that same period.

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