UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063193 |
|---|---|
| Receipt number | R000072263 |
| Scientific Title | Bronchiectasis Understanding and Research on Daily Experiences and Needs (BURDEN) : Online survey in Japanese patients with bronchiectasis (J-BURDEN Initiative Study) |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/06 18:40:48 |
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Basic information
Public title
Bronchiectasis Understanding and Research on Daily Experiences and Needs(BURDEN) : Online survey in Japanese patients with bronchiectasis(J-BURDEN Initiative Study)
Acronym
J-BURDEN Initiative Study
Scientific Title
Bronchiectasis Understanding and Research on Daily Experiences and Needs (BURDEN) : Online survey in Japanese patients with bronchiectasis (J-BURDEN Initiative Study)
Scientific Title:Acronym
J-BURDEN Initiative Study
Region
| Japan |
Condition
Condition
Bronchiectasis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the stable-state daily burden and the incremental burden of exacerbations among Japanese patients with non-cystic fibrosis bronchiectasis (NCFBE). This exploratory study also aims to identify associations between patient characteristics and disease burden.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Stable-state disease burden
2.Incremental disease burden from exacerbations
3.Health-related quality of life (HRQoL)
Key secondary outcomes
1.Exploratory associations among participant characteristics disease burden measures, and SF-6Dv2 outcomes
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.Confirmed diagnosis of bronchiectasis (without cystic fibrosis [CF]).
2.Currently symptomatic NCFBE.
3.At least one pulmonary exacerbation within the past year.
4.Aged 18 years or older at the time of providing consent.
5.Currently residing in Japan.
6.Able to understand written Japanese and self-complete the questionnaires.
7.Willing to participate in the study as evidenced by the consent process.
Key exclusion criteria
1.Diagnosis of cystic fibrosis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Tsuchiya |
Organization
Insmed GK.
Division name
Medical Affairs Department
Zip code
104-0014
Address
13F Tokyu Capitol Tower, 2-10-3, Nagatacho, Chiyoda-ku, Tokyo
TEL
080-3714-7945
takanori.tsuchiya@insmed.com
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Tsuchiya |
Organization
Insmed GK.
Division name
Medical Affairs Department
Zip code
104-0014
Address
13F Tokyu Capitol Tower, 2-10-3, Nagatacho, Chiyoda-ku, Tokyo 104-0014
TEL
080-3714-7945
Homepage URL
takanori.tsuchiya@insmed.com
Sponsor or person
Institute
Insmed GK.
Institute
Department
Personal name
Funding Source
Organization
Insmed GK.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
INTAGE Healthcare Inc., CLINICAL STUDY SUPPORT, Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, 180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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 | 10 | 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
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 | 08 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072263
