Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062150) titled 'A study on the association between antigen avoidance and recurrence in non-fibrotic hypersensitivity pneumonitis' on July 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - hypersensitivity pneumonitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To prospectively investigate the recurrence rate in patients with non-fibrotic hypersensitivity pneumonitis. Basic objectives2 - Others

Intervention: Interventions/Control_1 - antigen avoidance

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 Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2030 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071125

Disclaimer: Curated by HT Syndication.