UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062409 |
|---|---|
| Receipt number | R000071417 |
| Scientific 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 |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 15:03:02 |
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Basic information
Public title
Emotional and Social Experiences of Antifibrotic (AF) Therapy among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study
Acronym
Emotional and Social Experiences of Antifibrotic (AF) Therapy among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study
Scientific 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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF)
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
What are the attitudes toward and experiences of the emotional and/or social impact of side effects associated with AF treatment among Japanese patients with IPF/PPF, and how are these attitudes associated with patients' individual characteristics?
Basic objectives2
Others
Basic objectives -Others
To quantitatively evaluate, in a descriptive and exploratory manner using the PESaM, the attitudes of Japanese patients with IPF/PPF regarding the emotional and social impact associated with their AF treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key exclusion criteria
-Patients treated with nerandomilast (including clinical trials)
-Patients with PPF treated with pirfenidone
-Patients currently hospitalized
-Patients with malignant tumors
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Terayama |
Organization
Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs Group 2, Medicine Dept. 1, Clinical Development Medical Affairs ILD and inflammation,Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo
TEL
03-6417-2200
hiromi.terayama@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tobe |
Organization
Mebix, Inc.
Division name
Medical Science & Writing Group
Zip code
107-0052
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
IPFPPFptsurvey2025@mebix.co.jp
Sponsor or person
Institute
Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2 Nihonbashi-kayabacho, Chuo-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Large-Scale Cross-Sectional Study Using an Online Patient-Reported Outcome Questionnaire
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071417
