Idiopathic Pulmonary FibrosisNCT07743996
Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study
An observational study of Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
- How many people
- 122 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients treated with nerandomilast (including clinical trials)
- Patients with PPF treated with pirfenidone
- Patients currently hospitalized
- Patients with malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Japanese patients with IPF/PPF | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
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.
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Secondary outcomes (8)
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
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.
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the EQ-5D-5L
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.
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the SDM-Q-9
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).
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Reliability (Cronbach's α) of PESaM side effects sub-domain
To evaluate the reliability of the PESaM side effects sub-domain, Cronbach's alpha will be calculated.
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain
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.
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Correlation between PESaM side effects sub-domain and SDM-Q-9
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).
Measured: 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
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
Measured: 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
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
Measured: Assessed once at survey completion (approximately 20 minutes after survey initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743996
- Sponsor's protocol ID
- 1305-0170
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07743996
- Acronym / sponsor ID
- 1305-0170
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Japanese patients with IPF/PPF | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients treated with nerandomilast (including clinical trials)
- Patients with PPF treated with pirfenidone
- Patients currently hospitalized
- Patients with malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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).
Mean (95% CI) scores for the EQ-5D-5L
Time frame: 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).
Reliability (Cronbach's α) of PESaM side effects sub-domain
Time frame: 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).
Correlation between PESaM side effects sub-domain and SDM-Q-9
Time frame: 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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.