UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062549 |
|---|---|
| Receipt number | R000071600 |
| Scientific Title | Sequential target trial emulation using JMDC insurer and older-adult databases: 12-month effects of azithromycin maintenance therapy in non-cystic-fibrosis bronchiectasis |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 22:43:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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)
Acronym
Bronchiectasis Macrolide Maintenance TTE Study (JMDC)
Scientific Title
Sequential target trial emulation using JMDC insurer and older-adult databases: 12-month effects of azithromycin maintenance therapy in non-cystic-fibrosis bronchiectasis
Scientific Title:Acronym
Bronchiectasis Azithromycin Maintenance TTE Study (JMDC)
Region
| Japan |
Condition
Condition
Non-cystic-fibrosis bronchiectasis (adults with a high exacerbation burden).
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the mean cumulative number of treated respiratory exacerbations over 12 months from time zero (treated exacerbations are defined as episodes separated by at least 21 days). The per-protocol effect of initiating and sustaining azithromycin maintenance versus not initiating a maintenance macrolide is estimated using artificial censoring and inverse probability weighting in the sequential TTE, with 95% CIs from a patient-level bootstrap.
Key secondary outcomes
Secondary: time to first treated exacerbation and time to qualifying respiratory hospitalization; separate erythromycin and clarithromycin maintenance emulations when their estimability gates are met; active-comparator new-user comparisons of azithromycin initiators versus erythromycin and clarithromycin initiators; claims-defined safety outcomes (serious ventricular arrhythmia or cardiac arrest, newly diagnosed hearing disorder, pair-specific drug-drug-interaction outcomes, serious liver injury, and all-cause death) using endpoint-specific risk windows; exploratory pulmonary NTM; and transportability and heterogeneity between the insurer and older-adult databases without individual-level pooling.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
Homepage URL
kutsuna@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The University of Osaka Hospital, Ethical Review Board
Address
2-15, Yamadaoka, Suita city
Tel
0836-6879-5111
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a monthly sequential target trial emulation (with cloning, artificial censoring, and inverse probability weighting) using the JMDC insurer database (January 2005 to May 2025; primary time zeros April 2013 to June 2024) and older-adult database. Among stable adults with non-cystic-fibrosis bronchiectasis and a high exacerbation burden, initiation and sustained use of azithromycin maintenance is compared with no maintenance macrolide, estimating the 12-month per-protocol effect on the mean cumulative number of treated respiratory exacerbations. Databases are analyzed separately. This is a prospective registration before analysis and without reference to outcomes. Existing anonymized data are analysed after institutional review board approval.
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071600
