UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034466 |
|---|---|
| Receipt number | R000039308 |
| Scientific Title | Effects of once-daily use of inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) on the lung function in Japanese patients with ssthma |
| Date of disclosure of the study information | 2018/10/12 |
| Last modified on | 2019/04/18 14:15:03 |
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Basic information
Public title
Effects of once-daily use of inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) on the lung function in Japanese patients with ssthma
Acronym
Lung function change by FF/VI
Scientific Title
Effects of once-daily use of inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) on the lung function in Japanese patients with ssthma
Scientific Title:Acronym
Lung function change by FF/VI
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Japanese drug use system allowed the "once-daily use" of inhaled corticosteroid (fluticasone furoate) combined with a long acting beta-2 agonist (vilanterol) against asthma for the first time in 2013. We investigated the real-world efficacy and problems of this drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of lung function test data
Key secondary outcomes
Questions on the control of asthma, side effects, and preference of drug are asked.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prior treatments of asthma (twice-daily use of inhaled steroids with or without long-acting beta-2 agonists) were changed to once-daily use of fluticasone furoate (FF)/vilanterol(VI) (200 microgram/25 microgram). Subjects were evaluated by lung function tests prior to, and 2-3 months after, the initiation of FF/VI
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with astmam had to be already satisfied with their current treatment with regular maintenance inhalation therapy with inhaled corticosteroid (ICS) alone or ICS combined with a long acting beata-2 agonist.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Umeda |
Organization
International University of Health and Welfare Shioya Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Tomita 77, Yaita-City, Tochigi 329-2145, Japan
TEL
0287-44-1155
umeda@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Takahashi |
Organization
International University of Health and Welfare Hospital
Division name
Ethics Committee
Zip code
Address
Iguchi 537-3, Nasushiobara-City, Tochigi 329-2763, Japan
TEL
0287-39-3060
Homepage URL
masa-takahashi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
