Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062549) titled 'A study of whether initiating long-term azithromycin (macrolide) maintenance therapy reduces respiratory exacerbations over 12 months, and its harms, among adults with non-cystic-fibrosis bronchiectasis and frequent exacerbations, using health insurance claims data (sequential target trial emulation)' on Aug. 10.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Non-cystic-fibrosis bronchiectasis (adults with a high exacerbation burden). Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using the JMDC insurer and older-adult databases (analyzed separately), to estimate, among stable adults with non-cystic-fibrosis bronchiectasis and a high exacerbation burden, the 12-month per-protocol effect of initiating azithromycin maintenance therapy during days 0-29 and sustaining prescription coverage, versus not initiating any maintenance macrolide, on the mean cumulative number of treated respiratory exacerbations. A monthly sequential target trial emulation with cloning, artificial censoring, and inverse probability weighting is used. Erythromycin and clarithromycin maintenance, active-comparator comparisons, and safety outcomes are evaluated as secondary questions. This registration is performed before analysis and without reference to outcomes (before feasibility gates). Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Age 18 years or older at time zero. (2) At least 12 complete calendar months of continuous enrollment before time zero (verified uninterrupted spell or monthly enrollment table). (3) Non-cystic-fibrosis bronchiectasis: non-suspected J47 in at least 2 distinct outpatient claim months in the prior 12 months, or qualifying inpatient J47 as principal, admission-triggering, or highest-resource diagnosis. (4) High exacerbation burden: at least 2 treated exacerbations or at least 1 qualifying respiratory hospitalization during days -365 to -31. (5) If the restricted extract is used, at least 1 systemic antibacterial claim equivalent to J01 during days -365 to -1. (6) Stable window: no treated exacerbation, respiratory admission, new systemic antibacterial, or new systemic corticosteroid burst during days -30 to -1. (7) New treatment episode: no maintenance azithromycin, erythromycin, or clarithromycin coverage during days -365 to -1 or carried into day 0. (8) No recorded pulmonary NTM (A31.0) before time zero. JMDC insurer database (2005-2025; primary time zeros April 2013 to June 2024) and older-adult database are analyzed separately. Key exclusion criteria - Cystic fibrosis, lung transplant, claims-detectable pregnancy, or a prespecified absolute contraindication to the treatment strategy. A recorded pulmonary NTM (A31.0) diagnosis or NTM multidrug regimen before time zero. Maintenance macrolide use during days -365 to -1. Not meeting the stable window. Less than 12 months of continuous enrollment, or inability to verify enrollment continuity. Target Size - 10000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 08 Month 10 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071600

Disclaimer: Curated by HT Syndication.