An observational study in Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, sponsored by Avraham Unterman. Recruiting at 4 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Avraham Unterman · Observational
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.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 70 is below the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →This is the only study on the registry with Avraham Unterman as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Consecutive adults with IPF or PPF followed at one of the participating medical centers who initiate nerandomilast as part of routine clinical care during the enrollment period. Since this is a registry-based study, patients need to be included in a prospective ILD registry in order to participate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are diagnosed with IPF
Drug: Nerandomilast
Either Nerandomilast 9mg twice a day or 18mg twice a day
Adverse events
Proportion of participants experiencing prespecified adverse events (diarrhea, weight loss, nausea, cough, upper respiratory tract infection, dyspnea, nasopharyngitis, worsening of underlying condition, depression, anxiety), reported overall and by severity.
Time frame: Through study completion, an average of 9 months
Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year)
Average for all participants. For each participant, the annualized slope of absolute forced vital capacity over the period preceding nerandomilast initiation (derived from at least two pre-treatment measurements obtained within the previous 24 months) is compared with the annualized slope during 12 months of treatment. Each participant serves as their own control; the outcome is the within-participant difference between the two slopes, in mL/year, with a positive value indicating attenuation of decline on treatment.
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of FVC decline (% predicted/year)
As for outcome 2, with FVC expressed as percentage of predicted value.
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Difference between pre-treatment and on-treatment annualized rate of DLCO decline (% predicted/year)
As above, for diffusing capacity of the lungs for carbon monoxide, corrected for hemoglobin.
Time frame: Up to 24 months before initiation and, on average, 6 months after initiation
Change from baseline in K-BILD domain scores
Breathlessness and activities, psychological, and chest symptoms domains, each scored 0-100, higher indicating better health status.
Time frame: Baseline and 6-12 months
Change from baseline in FVC (mL and % predicted)
Absolute annualized change in forced vital capacity from the pre-treatment baseline measurement.
Time frame: Baseline and >6 months
Change from baseline in DLCO (% predicted)
Absolute annualized change in hemoglobin-corrected diffusing capacity from the pre-treatment baseline measurement.
Time frame: Baseline and >6 months
Incidence of serious adverse events
Proportion of participants with at least one serious adverse event, defined as an event that is fatal, life-threatening, requires or prolongs hospitalization, or results in persistent or clinically significant disability.
Time frame: Through study completion, an average of 9 months
Permanent discontinuation of nerandomilast
Proportion of participants permanently discontinuing nerandomilast, time to discontinuation, and reason for discontinuation.
Time frame: Through study completion, an average of 9 months
Dose reduction of nerandomilast
Proportion of participants in whom nerandomilast dose is reduced, time to dose reduction, and reason for dose reduction.
Time frame: Through study completion, an average of 9 months
Annualized incidence of acute exacerbation of interstitial lung disease
Number and proportion of participants with at least one acute exacerbation, defined according to published criteria, time to exacerbation.
Time frame: Through study completion, an average of 9 months
Annualized incidence of respiratory-cause hospitalization
Annualized incidence of respiratory-cause hospitalization
Time frame: Through study completion, an average of 9 months
Annualized all-cause mortality
Proportion of participants who die from any cause during follow-up.
Time frame: Through study completion, an average of 9 months
Annualized incidence of lung transplantation
Proportion of participants undergoing lung transplantation during follow-up.
Time frame: Through study completion, an average of 9 months
Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy
Primary and key secondary outcomes reported separately for IPF versus PPF, and for background nintedanib, pirfenidone, or no background antifibrotic therapy.
Time frame: Through study completion, an average of 9 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.
Of 74 non-industry observational studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 110. This study's planned 16 months is below that.
Counting every sponsor, half of 88 studies reached it within 54 months; a quarter within 29 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Idiopathic Pulmonary Fibrosis →