UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046813 |
|---|---|
| Receipt number | R000053419 |
| Scientific Title | Exploratory research for induced sputum obtained from the subjects with COPD who participated in the TRACK study in Kurume University Hospital |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2023/08/07 13:49:31 |
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Basic information
Public title
Exploratory research for the remaining clinical samples obtained from the subjects who participated in the TRACK study [Efficacy and safety of once-daily single-Inhaler TRiple (Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu] in Kurume University Hospital
Acronym
Exploratory research for the remaining clinical samples obtained from the subjects with COPD who participated in the TRACK study in Kurume University Hospital
Scientific Title
Exploratory research for induced sputum obtained from the subjects with COPD who participated in the TRACK study in Kurume University Hospital
Scientific Title:Acronym
Exploratory research for induced sputum in COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in induced sputum in patients with COPD after Triple therapy when compared with those after LAMA/LABA combination therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of induced sputum pre- and post-treatment between triple and LAMA/LABA combination therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Triple therapy
Interventions/Control_2
LAMA/LABA combination therapy
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD
Key exclusion criteria
severe and very severe
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | - |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | - |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
Homepage URL
http://www.kurume-u.ac.jp/
i_rinri@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center in Kurume University
Address
67 Asahi-machi, Kurume
Tel
+81942317560
i_rinri@kurume-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053419
