UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041089 |
|---|---|
| Receipt number | R000046926 |
| Scientific Title | Comparative efficacy of fluticasone furoate/umeclidinium/vilanterol(FF/UMEC/VI)versus budesonide/glycopyrrolate/formoterol fumarate(B/G/F) therapies in COPD patients |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2022/11/02 23:29:10 |
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Basic information
Public title
Comparative efficacy of fluticasone furoate/umeclidinium/vilanterol(FF/UMEC/VI)versus budesonide/glycopyrrolate/formoterol fumarate(B/G/F) therapies in COPD patients
Acronym
Comparative efficacy of triple therapies
Scientific Title
Comparative efficacy of fluticasone furoate/umeclidinium/vilanterol(FF/UMEC/VI)versus budesonide/glycopyrrolate/formoterol fumarate(B/G/F) therapies in COPD patients
Scientific Title:Acronym
Comparative efficacy of triple therapies
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the difference in characteristics between FF/UMEC/VI and B/G/F.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the efficacy of these inhalers after one month treatment
Key secondary outcomes
to identify the characteristics of the patients based on the efficacy with FF/UMEC/VI and B/G/F
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
fluticasone furoate/umeclidinium/vilanterol
Interventions/Control_2
Budesonide Glycopyrronium Bromide Formoterol Fumarate Hydrate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inhalable COPD patients
Key exclusion criteria
patients with HOT
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miyao |
Organization
Nippon Koukan Hospital
Division name
Pulmonary division
Zip code
2100852
Address
1-2-1, koukandori, kanawasaki-ku kawasaki
TEL
0443335591
kengo-ootsuka@koukankai.or.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Miyao |
Organization
Nippon Koukan Hospital
Division name
Pulmonary division
Zip code
2100852
Address
1-2-1, koukandori, kanawasaki-ku kawasaki
TEL
0443335591
Homepage URL
kengo-ootsuka@koukankai.or.jp
Sponsor or person
Institute
Nippon Koukan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Koukan Hospital
Address
1-2-1, koukandori, kanawasaki-ku kawasaki
Tel
0443335591
kengo-ootsuka@koukankai.or.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
| 2020 | Year | 07 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | 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
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046926
