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NCT Number: NCT07743996

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Progressive Pulmonary Fibrosis Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 141-6017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients capable of responding to a self-administered questionnaire

Exclusion criteria

  • Patients treated with nerandomilast (including clinical trials)
  • Patients with PPF treated with pirfenidone
  • Patients currently hospitalized
  • Patients with malignant tumors

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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