UMIN-ICDS Clinical Trial

Public title

Exposome Assessment and Intervention in Hypersensitivity Pneumonitis

Acronym

Exposome Assessment and Intervention in Hypersensitivity Pneumonitis

Scientific Title

Exposome Assessment and Intervention in Hypersensitivity Pneumonitis

Scientific Title:Acronym

Exposome Studies in Hypersensitivity Pneumonitis

Region

Japan

Condition

Hypersensitivity Pneumonitis

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Hypersensitivity pneumonitis is an intractable allergic/immune disease in which repeated inhalation of various antigens causes type III/IV allergic inflammation and fibrosis in the alveoli and bronchioles. It is classified into "non-fibrotic hypersensitivity pneumonia" with acute symptoms and "fibrotic hypersensitivity pneumonia" with a chronic course. The cause of fibrosis in fibrotic hypersensitivity pneumonia is unknown, and no treatment other than antigen avoidance has been established.
Until now, patients with a diagnosis or suspicion of hypersensitivity pneumonitis have generally been instructed to avoid antigens and then monitored for changes in clinical course (serum markers and respiratory function), but there is no standardized method of antigen avoidance, nor is there a fixed index for evaluation.
Therefore, for cases diagnosed with hypersensitivity pneumonitis and requiring antigen avoidance, air conditioners are cleaned by cleaners, using air purifiers, and physicians and nurses educate patients and their families about the exposome (environmental factors to which individuals are exposed). Antigen levels of bacteria, fungi, and other antigenic substances will be measured by qPCR and ELISA on dust in the environment before and after the uniform intervention and cleaning to (1) objectively measure changes in the exposome and (2) prospectively investigate changes in the clinical course after antigen avoidance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Difference in change in environmental antigen levels between the two groups from the start of the study to 52 weeks
Difference in change in effort lung capacity (FVC) and %FVC between the two groups from the start of the study to 52 weeks

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Internal cleaning of air conditioners by cleaners
Installation of air purifiers
Patient and family education by doctors and nurses

Interventions/Control_2

Conventional antigen avoidance guidance by attending physician

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with a history of hospital visit or hospitalization between April 1, 2023 and March 31, 2025 at the Department of Respiratory Medicine, Tokyo Medical and Dental University Hospital and the collaborating institutions (Ome Municipal General Hospital, Hiratsuka Kyosai Hospital, Yamanashi Prefectural Central Hospital, Japanese Red Cross Musashino Hospital, Tsuchiura Kyodo General Hospital, Tokai University Hospital, Kanagawa Cardiovascuiar and Respiratory Center), Patients who have been diagnosed with hypersensitivity pneumonia (low-confidence cases or higher in the Hypersensitivity Pneumonia Clinical Practice Guidelines 2022) and whose causative antigen is presumed to be avian or fungi/bacteria in the residence. In addition, patients who meet the following criteria will be considered
The investigator determines that the disease is not associated with hypersensitivity pneumonitis at the time of screening and is expected to have a life expectancy of at least 24 months.
Patients who are willing and able to comply with the prescribed study protocol for treatment and evaluation during the study period.

Key exclusion criteria

Minors
Patients who are judged by the principal investigator/researcher to be ineligible for participation in the study
Patients for whom respiratory function tests cannot be performed
Use of certain doses of steroids, cyclosporine A, or tacrolimus at doses greater than 10 mg/day of prednisolone equivalent within 4 weeks prior to screening and planned during the study period
Pregnancy or planned pregnancy during the study period
Patients who refused to participate in the study
Patients who are smoking at the time of inclusion
Patients who have no air conditioning in their residence
Patients who plan to move within 1 year or relocate for more than 4 weeks.

Target sample size

60

Name of lead principal investigator

1st name	Tsukasa
Middle name
Last name	Okamoto

Organization

Tokyo Medical and Dental University

Division name

Department of Pulmonary Immunotherapeutics

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5954

Email

tokapulm@tmd.ac.jp

Name of contact person

1st name	Tsukasa
Middle name
Last name	Okamoto

Organization

Tokyo Medical and Dental University

Division name

Department of Pulmonary Immunotherapeutics

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5954

Homepage URL

Email

tokapulm@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

apan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Medical and Dental University Hospital, Clinical Research Center

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5612

Email

tiken.crc@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

06

Month

15

Day

Date of IRB

2023

Year

06

Month

15

Day

Anticipated trial start date

2023

Year

06

Month

15

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

08

Month

03

Day

Last modified on

2023

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059126