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Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study

10. August 2026 aktualisiert von: Boehringer Ingelheim

A Real-World Study of the Perceived Emotional and Social Experiences Related to Antifibrotic Therapy in Patients With IPF and PPF: A Cross-Sectional Web-Based Survey

This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire.

This study tries to find out the attitudes toward and experiences of the emotional and/or social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Japan
      • Tokyo, Japan, 141-6017
        • Rekrutierung
        • Nippon Boehringer Ingelheim Co., Ltd.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

The study population will consist of patients with IPF and PPF who meet the inclusion criteria and do not meet any exclusion criteria (outlined below), and have provided informed consent to participate in the study using an electronic informed consent form (eICF).

Beschreibung

Inclusion Criteria:

  1. Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks
  2. Patients capable of responding to a self-administered questionnaire

Exclusion Criteria:

  1. Patients treated with nerandomilast (including clinical trials)
  2. Patients with PPF treated with pirfenidone
  3. Patients currently hospitalized
  4. Patients with malignant tumors

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Japanese patients with IPF/PPF

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The score of patient experiences and satisfaction with medications (PESaM) side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Assessed once at survey completion (approximately 20 minutes after survey initiation).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the EQ-5D-5L
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The quality of life (Qol) 5 dimensions 5-level (EQ-5D-5L) index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the SDM-Q-9
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The 9-Item Shared Decision-Making Questionnaire (SDM-Q-9) score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making).
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Reliability (Cronbach's α) of PESaM side effects sub-domain
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).
To evaluate the reliability of the PESaM side effects sub-domain, Cronbach's alpha will be calculated.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

EQ-5D-5L index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Correlation between PESaM side effects sub-domain and SDM-Q-9
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The 9-Item SDM-Q-9 score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making).
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Descriptive statistics of patient background in high- and low-score groups for the PESaM side effects sub-domain
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The following descriptive statistics will be reported:

  • Sex
  • Age
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Clinical characteristics in high- and low-score groups for the PESaM side effects sub-domain
Zeitfenster: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The following clinical characteristics will be reported:

  • Lung diseases group
  • AF treatment in use
  • Disease duration
  • Severity/use of oxygen therapy
Assessed once at survey completion (approximately 20 minutes after survey initiation).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

30. September 2026

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. August 2026

Zuerst gepostet (Tatsächlich)

4. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1305-0170

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-Sharing-Zeitrahmen

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-Sharing-Zugriffskriterien

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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