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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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Giappone
      • Tokyo, Giappone, 141-6017
        • Reclutamento
        • Nippon Boehringer Ingelheim Co., Ltd.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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).

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Japanese patients with IPF/PPF

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

24 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 agosto 2026

Primo Inserito (Effettivo)

4 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1305-0170

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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