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NCT07919015Recruiting

Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

A Prospective, Multicenter, Observational Real-world Study of Nerandomilast Efficacy and Safety in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
21 Oct 2026
Start date
1 Feb 2026
Primary completion date
30 Jun 2027
Lead sponsor
Avraham Unterman
NCT number
NCT07919015

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Feb 2026 to the primary completion date, 30 Jun 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Barzilai Medical Center, Ben-Gurion University of the Negev
Coordinator of this site? Confirm its status
AshkelonIsraelRecruiting
Rambam Health Care Campus, Technion - Israel Institute of Technology
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Sheba Medical Center, Tel-HaShomer, Tel-Aviv University
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Tel-Aviv Sourasky University Medical Center, Tel-Aviv University
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.