UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061199 |
|---|---|
| Receipt number | R000070012 |
| Scientific Title | Post-Treatment Evolution of Bronchiectasis in Patients Recovered from NTM pulmonary disease |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 16:56:26 |
* 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 investigating the clinical course of bronchiectasis after treatment for nontuberculous mycobacterial pulmonary disease
Acronym
Post NTM Bronchiectasis
Scientific Title
Post-Treatment Evolution of Bronchiectasis in Patients Recovered from NTM pulmonary disease
Scientific Title:Acronym
Post NTM Bronchiectasis
Region
| Japan |
Condition
Condition
Bronchiectasis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical course and characteristivs of bronchiectasis after treatment for nontuberculous mycobacterial pulmonary disease.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients who develop a chronic bacterial infection.
Key secondary outcomes
The frequency and the risks factors of chronic bacterial infection after the end of NTMPD treatment.
The frequency of bronchiectasis exacerbations and radiological changes in patients with chronic infections.
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
Patients who received treatment for nontuberculous mycobacterial pulmonary disease at Fukujuji Hospital between January 2006 and Novemnber 2019, achieved microbiological cure, and completed treatment.
Key exclusion criteria
HIV positive
Patients without bronchiectasis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Morimoto |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
204-852
Address
3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL
0424914111
morimotok@fukujuji.org
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Ito |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
204-852
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo, Japan
TEL
0424914111
Homepage URL
masashiito.fj@gmail.com
Sponsor or person
Institute
Japan Anti-Tuberculosis Association, Fukujuji Hospital
Institute
Department
Personal name
Funding Source
Organization
Insmed Incorporated
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Fukujuji Hospital, Japan Anti-Tuberculosis Association
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo, Japan
Tel
0424914111
masashiito.fj@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 08 | 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
400
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study using existing clinical data.
Therefore, no new patient recruitment or enrollment will be conducted.
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070012
