Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063490) titled 'A study of the relationship between inflammatory findings at diagnosis and early changes in lung function in patients with interstitial lung disease who start nerandomilast' on Nov. 2.

Study Type: Observational

Primary Sponsor: Institute - Sapporo Medical University

Condition: Condition - Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To explore the association between lymphocyte-predominant inflammatory findings at diagnosis (lung histology and bronchoalveolar lavage cell differential) and the early trajectory of forced vital capacity (FVC) up to week 24 in patients with IPF or PPF who start nerandomilast as part of routine care. Patients are followed to week 52, and the feasibility of a prospective cohort with deep phenotyping (histology, BAL, serum biomarkers) is assessed. As a reference, existing clinical data of all eligible patients who started pirfenidone or nintedanib between December 2008 and 31 July 2026 are collected retrospectively. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Diagnosis of fibrosing interstitial lung disease (IPF or PPF). IPF per the 2022 ATS/ERS/JRS/ALAT guideline; PPF per the same guideline (at least two of worsening respiratory symptoms, physiological progression and radiological progression within the past year, counted from the date the decision to start nerandomilast was made). 2) Decision made, as part of routine care, to newly start nerandomilast 3) Age 20 years or older at consent 4) Written informed consent given by the patient Key exclusion criteria - 1) Consent not obtained 2) Judged unsuitable for participation by the principal investigator or a co-investigator (Concomitant antifibrotic therapy is not an exclusion criterion; such patients form the add-on group and are analysed separately from the primary analysis.) Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 26 Day Anticipated trial start date - 2026 Year 11 Month 03 Day Last follow-up date - 2031 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072665

Disclaimer: Curated by HT Syndication.