UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Title of the study (Brief title)	Evaluation of the clinical efficacy of flutiform®(fluticasone propionate /formoterol fumarate) on severe persistent bronchial asthma
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of high doses of Flutiform will be investigated in a comparison with high doses of conventional treatments on patients with severe persistent asthma which is not well controlled with medium doses of ICS/LABA (dry powders).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Asthma control questionnaire (ACQ)
Key secondary outcomes	Pulmonary function tests (FEV1, %FEV1, FEV1%, V25, V50), FeNO, IOS indices (R5, R20, R5-R20, X5, Ax), the number of times rescue medications are used (oral steroids, infusion (steroids/aminophylline), SABA)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	<Observation period> Medium dose of ICS/LABA combination (dry powders) for 4 weeks <Treatment period> High dose of Flutiform&reg; (4 puff twice daily) for 8 weeks
Interventions/Control_2	<Observation period> Medium dose of ICS/LABA combination (dry powders) for 4 weeks <Treatment period> High of pretreatment drug for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	<Observation period> (1) Adult patients with asthma (2) Outpatients (3) Those who are receiving Step-3 treatment in accordance with the "asthma prevention and management guideline 2012 (JGL2012)" (4) Those who have been treated with ICS/LABA (medium doses, DPI formulation) for more than 4 weeks (5) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012 (6) Those who understand an explanation about the present study and can give written informed consent *Those who fulfill the inclusion criteria above and have been treated without a dose change during the 4 weeks before informed consent are allowed to immediately enter the treatment period. <Treatment period> Those who fulfill the criteria below at the end of the observation period can enter the treatment period. (1) Those who are receiving Step-3 treatment in accordance with the JGL2012 (2) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012 (3) Those who were treated without a dose change during the observation period
Key exclusion criteria	(1) Patients with COPD (2) Patients who take SABA other than treatment of exacerbations (3) Patients who had a history of adverse reaction to ICS or LABA (4) Patients who took flutiform &reg; within four weeks (5) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease (6) Current malignancy (7) Smoking within past 1 year (8) Those who are pregnant, under-lactation, or desire pregnancy (9) Unsuitability as determined by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshiki Ishii
Organization	Dokkyo Medical University Hospital
Division name	Department of Pulmonary Medicine and Clinical Immunology
Address	880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-87-2151
Email	ishiiysk@dokkyomed.ac.jp

Public contact
Name of contact person	Mori Nobuhide
Organization	Research Administration Office (Mebix, Inc.)
Division name	Research Promotion Office
Address	Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan
TEL	03-4362-4504
Homepage URL
Email	flutiform@mebix.co.jp

Sponsor
Institute	Dokkyo Medical University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	KYORIN Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 23 Day
Last follow-up date	2016 Year 01 Month 05 Day
Date of closure to data entry	2016 Year 02 Month 29 Day
Date trial data considered complete	2016 Year 03 Month 15 Day
Date analysis concluded	2016 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 20 Day
Last modified on	2016 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000019568