UMIN-CTR Clinical Trial

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
Last 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
1st 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