UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062150 |
|---|---|
| Receipt number | R000071125 |
| Scientific Title | A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/10 19:02:29 |
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Basic information
Public title
A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis
Acronym
A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis
Scientific Title
A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis
Scientific Title:Acronym
A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis
Region
| Japan |
Condition
Condition
hypersensitivity pneumonitis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the recurrence rate in patients with non-fibrotic hypersensitivity pneumonitis.
Basic objectives2
Others
Basic objectives -Others
To explore biomarkers associated with recurrence and to evaluate causative antigens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-year recurrence rate after antigen avoidance based on the causative antigen in non-fibrotic hypersensitivity pneumonitis
Key secondary outcomes
Changes from the start of the intervention to Week 104 in serum KL-6 and SP-D levels, pulmonary function test results (FVC and %FVC), radiological findings, patient-reported outcomes (KBILD and SF-36), environmental fungal burden, fungal microbiota, fungal antibody titres, and serum cytokine and chemokine levels.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
antigen avoidance
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 who have a history of outpatient visits or hospitalisation at the Department of Respiratory Medicine, Institute of Science Tokyo Hospital, or at participating research institutions (see attachment), between the date of ethics committee approval at each institution and 31 March 2028, and who are newly diagnosed with non-fibrotic hypersensitivity pneumonitis (with at least moderate confidence according to the 2022 Clinical Practice Guide for Hypersensitivity Pneumonitis). Patients who have been followed up for non-fibrotic hypersensitivity pneumonitis prior to the above period and who experience recurrence during this period will also be eligible.
Patients must also meet the following criteria:
The attending physician judges at the time of screening that the patient is expected to survive for at least 24 months.
The patient is willing and able to comply with the specified study protocol regarding treatment and with the assessments during the study period.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
Minors.
Patients whom the principal investigator or investigators judge to be unsuitable for participation in the study.
Patients who are unable to undergo pulmonary function testing.
Patients who are pregnant or planning to become pregnant during the study period.
Patients who have expressed their refusal to participate in the study.
Patients who are current smokers at the time of enrolment.
Patients with a confirmed diagnosis of an interstitial lung disease other than hypersensitivity pneumonitis.
Patients with active malignancy.
However, patients who are planning to move residence within 1 year or to be transferred to another workplace for 4 weeks or longer will not be excluded solely on this basis.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Okamoto |
Organization
Institute of Science Tokyo
Division name
The Center for Personalized Medicine for Healthy Aging
Zip code
1138510
Address
16th Floor, Building B, Institute of Science Tokyo Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4194
tokamoto.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Okamoto |
Organization
Institute of Science Tokyo
Division name
The Center for Personalized Medicine for Healthy Aging
Zip code
1138510
Address
16th Floor, Building B, Institute of Science Tokyo Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4194
Homepage URL
tokamoto.pulm@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Tsukasa Okamoto
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Institute of Science Tokyo
Address
Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.ac.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 | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071125
