UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Title of the study (Brief title)	Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort
Region	Japan

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

Objectives
Narrative objectives1	To compare the rapid onset of Flutiform with Relvar and Symbicort with pulmonary function test.
Basic objectives2	Others
Basic objectives -Others	Mean change of post-dose FEV1 from pre-dose FEV1 (3 minutes after inhalation)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean change of FEV1 from pre-dose FEV1 (3 minutes after inhalation)
Key secondary outcomes	1) Pulmonary function parameters Measured value at each evaluation point -Amount of change, change rate from pre-dose -AUC (change of amount from pre-dose) 2) Asthma control level -ACQ score -JACS score -Correlation between JACS and ACQ 3) Adverse Events

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single dose of Flutiform 125 Aerosol 2 puffs
Interventions/Control_2	Single dose of Symbicort Turbohaler 2 inhalations
Interventions/Control_3	Single dose of Relvar Ellipta single inhalationt
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	<Visit 0> (1) Patients who were diagnosed as bronchial asthma. (2) Men or women aged >=20 and <80 years on the date of consent. (3) Patients who are able to change ICS/LABA to ICS with same titer. (4) Patients who are able to visit in the morning. (5) Patients who can voluntary provide consent with sufficient understanding of participation. <Visit 1> (1) Patients who provide consent based on the informed consent document. (2) Patients whose severity of asthma were mild persistent or moderate persistent by JGL2015. (3) Patients who were step 2 or 3 by JGL2015. (4) Patients' symptoms in current treatment are "Controlled" or "Mild intermittent". (5) ACQ <= 0.75. (6) No asthma exacerbation during three months.
Key exclusion criteria	<Visit 1> (1) Obvious COPD, ACO. (2) >=10 pack-years. (3) Patients who are not able to operate inhaler device. (4) Patients who used ICS/LABA or changed the dose of ICS during Run-in period. (5) Patients who inhaled Flutide Diskus before visit. (6) Chronic airway infection. (7) Patients who are complicated with severe liver, kidney and heart disease. (8) Patients who merger malignant tumor. (9) Patients who are pregnant or are likely to be pregnant. (10) Patients who are inadequate as the study subjects.
Target sample size	15

Research contact person
Name of lead principal investigator	Hiroyuki Ohbayashi
Organization	Tohno Chuo Clinic
Division name	Respiratory medicine
Address	14-1, Matsugase-cho, 1-Chome, Mizunami-shi, Gifu, Japan
TEL	0572-67-1118
Email	aims_reserve@yahoo.co.jp

Public contact
Name of contact person	Hiroyuki Ohbayashi
Organization	Tohno Chuo Clinic
Division name	Respiratory medicine
Address	14-1, Matsugase-cho, 1-Chome, Mizunami-shi, Gifu, Japan
TEL	0572-67-1118
Homepage URL
Email	aims_reserve@yahoo.co.jp

Sponsor
Institute	Tohno Chuo Clinic
Institute
Department

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	東濃中央クリニック/Tohno Chuo Clinic

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 21 Day
Anticipated trial start date	2017 Year 10 Month 02 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 15 Day
Date trial data considered complete	2018 Year 02 Month 15 Day
Date analysis concluded

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

Management information
Registered date	2017 Year 10 Month 02 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033576