UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016136 |
|---|---|
| Receipt number | R000018737 |
| Scientific Title | A comparison of the efficacy of once-daily fluticasone furoate/vilanterole with twice-dily fluticasone propionate/salmeterol in elderly patients with asthma |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/01/06 17:27:34 |
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Basic information
Public title
A comparison of the efficacy of once-daily fluticasone furoate/vilanterole with twice-dily fluticasone propionate/salmeterol in elderly patients with asthma
Acronym
The efficacy of fluticasone furoate/vilanterole in elderly asthmatics
Scientific Title
A comparison of the efficacy of once-daily fluticasone furoate/vilanterole with twice-dily fluticasone propionate/salmeterol in elderly patients with asthma
Scientific Title:Acronym
The efficacy of fluticasone furoate/vilanterole in elderly asthmatics
Region
| Japan |
Condition
Condition
elderly asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of once-daily fluticasone furoate/vilanterole with twice-dily fluticasone propionate/salmeterol in elderly asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory functions
Key secondary outcomes
QOL
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
once-daily fluticasone furoate/vilanterole
Interventions/Control_2
twice-dily fluticasone propionate/salmeterol
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stable elderly asthma
Key exclusion criteria
Unsle elderly asthma
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumi-Hokubu-machi, Toyama City, Toyama, Japan
TEL
076-422-1112
ishiura@tch.toyama.toyama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumi-Hokubu-machi, Toyama City, Toyama, Japan
TEL
076-422-1112
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 01 | 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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 06 | Day |
Last modified on
| 2015 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018737
