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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034466
Receipt No. 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

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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
Email 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
Email masa-takahashi@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039308

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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