Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063119) titled 'A study of the efficacy and side effects of nelandmilast treatment in patients with interstitial lung disease' on Sept. 30.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto Prefectural University of Medicine
Condition:
Condition - idiopathic pulmonary fibrosis, progressive pulmonary fibrosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to prospectively evaluate the real-world efficacy and safety of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Additionally, this study examines the associations of patient characteristics, gut microbiota, and concomitant use of other anti-fibrotic agents with treatment outcomes and adverse events, in order to identify predictive factors for these outcomes and events.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who are scheduled to receive nerandomilast for idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
Patients who have received sufficient explanation of the study and provided written informed consent of their own free will.
Key exclusion criteria - Patients aged 17 years or younger at the initiation of nerandomilast.
Patients who are considered inappropriate for participation in this study by the treating physician for any other reason.
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 13 Day
Date of IRB - 2026 Year 08 Month 18 Day
Anticipated trial start date - 2026 Year 08 Month 18 Day
Last follow-up date - 2031 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072234
Disclaimer: Curated by HT Syndication.
