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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041089
Receipt No. 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 2020/07/13

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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
Email 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
Email kengo-ootsuka@koukankai.or.jp

Sponsor
Institute Nippon Koukan Hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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