Overview
Nerandomilast is an oral medicine that slows down the loss of functional residual capacity (FVC) in people with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It was tested in two large clinical trials in which participants were carefully selected. In everyday practice, patients are often older, have more other illnesses, or take additional medicines, and it is not known whether the benefits seen in the trials also occur outside them.
The Real-world Study of Nerandomilast (ReaSoN-IPF/PPF) follows people with IPF or PPF who begin nerandomilast as part of their usual medical care at several medical centers in Israel. The study does not assign any treatment; the treating physician makes every decision about therapy.
The main goal is to find out whether lung function declines more slowly once nerandomilast is started. Because patients have breathing tests before they begin the medicine as well as during treatment, each patient is compared with themselves: the rate at which their FVC was declining beforehand is compared with the rate following treatment.
The study also asks how patients feel, using a questionnaire called the K-BILD, and records side effects, hospital admissions, disease exacerbations, and whether patients stop the medicine.
Participants attend their normal clinic visits. They complete the questionnaire before treatment starts and again at 6 to 12 months, and their routine lung function results are collected. No extra tests or visits are required beyond the questionnaire.
Eligibility
Inclusion Criteria:
- Age 18 years or older.
- Physician-confirmed diagnosis of IPF according to current ATS/ERS/JRS/ALAT guidelines, or of PPF (fibrotic interstitial lung disease other than IPF meeting INBUILD criteria for progression).
- Initiating treatment with nerandomilast as part of routine clinical care, with the treatment decision made independently of, and prior to, study enrollment.
- Willing and able to provides written informed consent to participate in the prospective ILD registry of the respective medical center.
Exclusion Criteria:
- Prior exposure to nerandomilast, including in a clinical trial or open-label extension study.
- Concurrent participation in an interventional trial of an investigational agent for interstitial lung disease.
