Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis (ReaSoN-IPF/PPF)
A Prospective, Multicenter, Observational Real-world Study of Nerandomilast Efficacy and Safety in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Doron Cohn-Schwartz, MD, PhD
- Telefonnummer: 972-3-6973591
- E-post: doroncs@tlvmc.gov.il
Studer Kontakt Backup
- Navn: Avraham Unterman, MD, MBA
- Telefonnummer: 972-3-6973591
- E-post: ramiu@tlvmc.gov.il
Studiesteder
-
-
-
Ashkelon, Israel, 7830604
- Rekruttering
- Barzilai Medical Center, Ben-Gurion University of the Negev
-
Ta kontakt med:
- Ori Wand, MD
- Telefonnummer: 972-8-6745465
- E-post: oriw@bmc.gov.il
-
Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus, Technion - Israel Institute of Technology
-
Ta kontakt med:
- Yaniv Dotan, MD, PhD
- Telefonnummer: 972-4-8542648
- E-post: Y_dotan@rmc.gov.il
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Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center, Tel-HaShomer, Tel-Aviv University
-
Ta kontakt med:
- Liran Levy, MD
- Telefonnummer: 972-3-5302745
- E-post: Liran.Levy@sheba.health.gov.il
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Tel-Aviv Sourasky University Medical Center, Tel-Aviv University
-
Ta kontakt med:
- Doron Cohn-Schwartz, MD, PhD
- Telefonnummer: 972-3-6973591
- E-post: doroncs@tlvmc.gov.il
-
Ta kontakt med:
- Avraham Unterman, MD, MBA
- Telefonnummer: 972-3-6973591
- E-post: ramiu@tlvmc.gov.il
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
IPF or PPF
Patients who are diagnosed with IPF |
Either Nerandomilast 9mg twice a day or 18mg twice a day |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: Through study completion, an average of 9 months
|
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. |
Through study completion, an average of 9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year)
Tidsramme: Up to 24 months before initiation and, on average, 6 months after initiation
|
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. |
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)
Tidsramme: Up to 24 months before initiation and, on average, 6 months after initiation
|
As for outcome 2, with FVC expressed as percentage of predicted value. |
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)
Tidsramme: Up to 24 months before initiation and, on average, 6 months after initiation
|
As above, for diffusing capacity of the lungs for carbon monoxide, corrected for hemoglobin. |
Up to 24 months before initiation and, on average, 6 months after initiation
|
|
Change from baseline in K-BILD domain scores
Tidsramme: Baseline and 6-12 months
|
Breathlessness and activities, psychological, and chest symptoms domains, each scored 0-100, higher indicating better health status. |
Baseline and 6-12 months
|
|
Change from baseline in FVC (mL and % predicted)
Tidsramme: Baseline and >6 months
|
Absolute annualized change in forced vital capacity from the pre-treatment baseline measurement. |
Baseline and >6 months
|
|
Change from baseline in DLCO (% predicted)
Tidsramme: Baseline and >6 months
|
Absolute annualized change in hemoglobin-corrected diffusing capacity from the pre-treatment baseline measurement. |
Baseline and >6 months
|
|
Incidence of serious adverse events
Tidsramme: Through study completion, an average of 9 months
|
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. |
Through study completion, an average of 9 months
|
|
Permanent discontinuation of nerandomilast
Tidsramme: Through study completion, an average of 9 months
|
Proportion of participants permanently discontinuing nerandomilast, time to discontinuation, and reason for discontinuation. |
Through study completion, an average of 9 months
|
|
Dose reduction of nerandomilast
Tidsramme: Through study completion, an average of 9 months
|
Proportion of participants in whom nerandomilast dose is reduced, time to dose reduction, and reason for dose reduction. |
Through study completion, an average of 9 months
|
|
Annualized incidence of acute exacerbation of interstitial lung disease
Tidsramme: Through study completion, an average of 9 months
|
Number and proportion of participants with at least one acute exacerbation, defined according to published criteria, time to exacerbation. |
Through study completion, an average of 9 months
|
|
Annualized incidence of respiratory-cause hospitalization
Tidsramme: Through study completion, an average of 9 months
|
Annualized incidence of respiratory-cause hospitalization |
Through study completion, an average of 9 months
|
|
Annualized all-cause mortality
Tidsramme: Through study completion, an average of 9 months
|
Proportion of participants who die from any cause during follow-up. |
Through study completion, an average of 9 months
|
|
Annualized incidence of lung transplantation
Tidsramme: Through study completion, an average of 9 months
|
Proportion of participants undergoing lung transplantation during follow-up. |
Through study completion, an average of 9 months
|
|
Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy
Tidsramme: Through study completion, an average of 9 months
|
Primary and key secondary outcomes reported separately for IPF versus PPF, and for background nintedanib, pirfenidone, or no background antifibrotic therapy. |
Through study completion, an average of 9 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0101-21-TLV-A
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