UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055763 |
|---|---|
| Receipt number | R000063733 |
| Scientific Title | Preference study about pharmacological treatment for Japanese IPF patients |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2026/05/22 17:48:17 |
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Basic information
Public title
Preference study about pharmacological treatment for Japanese IPF patients
Acronym
IPF patient's pharmacological treatment preference study
Scientific Title
Preference study about pharmacological treatment for Japanese IPF patients
Scientific Title:Acronym
IPF patient's pharmacological treatment preference study
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis: IPF
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
- To understand and describe the differences in treatment attribute preferences of patients with IPF
- To quantitatively evaluate the relative importance of treatment attributes to patients with IPF when selecting pharmaceutical treatments
Basic objectives2
Others
Basic objectives -Others
Not Applicable
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
- Pharmacological treatment effect: evaluating the relative importance of treatment attributes to patients with IPF when selecting pharmaceutical treatments
- Pharmacological treatment preference: assessing the relative importance of treatment-related side effects (e.g., nausea, diarrhoea, photosensitivity) when selecting pharmaceutical treatments
Key secondary outcomes
- Exploring of IPF patient's unmet medical needs
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients are adults aged 40 years and older, diagnosed IPF by a physician (self-reported).
- Provide the evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study (electronic consent).
Key exclusion criteria
There are not exclusion criteria in this study.
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Ishii |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Medical Affairs Group 2, Medicine Dept. 1, Clinical Development Medical Affairs ILD and Respiratory, Medicine Dive
Zip code
141-0032
Address
Think Park Tower 2-1-1 Shinagawa-ku, Tokyo
TEL
03-6417-2200
tsuyoshi.ishii@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Ishii |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Medical Affairs Group 2, Medicine Dept. 1, Clinical Development Medical Affairs ILD and Respiratory,
Zip code
141-0032
Address
Think Park Tower 2-1-1 Shinagawa-ku, Tokyo
TEL
03-6417-2200
Homepage URL
tsuyoshi.ishii@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2024 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
86
Results
The difference in preference weights from no change in a benefit to the greatest amount of change in a benefit was largest for the expected survival benefit (64.72).
The difference in preference weights from no side effects to the most severe side effect was largest for nausea (-48.48). The changes for diarrhoea (-38.02) were less pronounced.
Results date posted
| 2026 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who participated in the quantitative survey had a mean age of 64 years, and 95.0% were male. More than 66.25% of patients experienced a body weight loss of more than 2 kg. Regarding antifibrotic therapy, 27.50% had experience with nintedanib and 11.25% with pirfenidone. In addition, 12.50% of patients reported dissatisfaction with their current treatment.
Qualitative interviews
Participants ranged in age from their 50s to 70s and consisted of three males and three females. Four patients (66.7%) had used nintedanib and two patients (33.3%) had used pirfenidone. All participants were diagnosed between 2021 and 2024.
Participant flow
Quantitative survey
An online discrete choice experiment (DCE) was conducted among patients recruited from disease-specific and general online panels provided by Rakuten Insight. The survey assessed preferences across seven treatment-related attributes, including treatment efficacy (overall survival, acute exacerbations, shortness of breath, and cough) and adverse events (diarrhea,nausea, and photosensitivity).
Qualitative interviews
Semi structured interviews lasting approximately one hour were conducted with patients between December 10 and December 25, 2024, based on an interview guide developed through desk research. Participants were recruited via an online patient community for interstitial lung disease patients
Adverse events
NA
Outcome measures
Quantitative survey:
Preference weights and relative attribute importance
Qualitative interviews:
Five key themes and 13 sub-themes identified through thematic analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Non-interventional study
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063733
