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

August 10, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Japanese patients with IPF/PPF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
Time Frame: 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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 24, 2026

First Submitted That Met QC Criteria

August 2, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Time Frame

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 Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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