UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of clinical efficacy between fluticasone propionate/ formoterol (FFC) and fluticasone furoate/ vilanterol (VFC) in patients with asthma
Acronym	Comparison of clinical efficacy between FFC and VFC
Scientific Title	Comparison of clinical efficacy between fluticasone propionate/ formoterol (FFC) and fluticasone furoate/ vilanterol (VFC) in patients with asthma
Scientific Title:Acronym	Comparison of clinical efficacy between FFC and VFC
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical efficacy of fluticasone propionate/formoterol compared to fluticasone furoate/vilanterol in asthmatic patients insufficiently or poorly controlled by inhaled steroids.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Period until patients insufficiently or poorly controlled on ICS therapy are determined to be well-controlled by switching to ICS/LABA therapy Evaluation at 24 Week visit
Key secondary outcomes	-Pulmonary functions Evaluation at 0, 2, 8, 16, and 24 Week visit -symptoms During research period -peak flow meter During research period <Control level> -JGL Evaluation at 0 and 24 Week visit -ACQ Evaluation at 0, 2, 8, 16, and 24 Week visit -JACS Evaluation at 0, 2, 8, 16, and 24 Week visit -Simulation for the percentage of patients/period of time until patients become well-controlled using ACQ/JACS Evaluation at 0, 2, 8, 16, and 24 Week visit -Device operability questionnaire Evaluation at 0 and 24 Week visit -Correlation between control level and symptoms -Control level (ACQ/JACS) Evaluation at 0, 2, 8, 16, and 24 Week visit

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	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Flutiform (20 patients) Brand name: Flutiform125 Aerosol Moderate dose: 500 micrograms per day Study Period: 24 weeks Frequency: 2 inhalations per dose, 2 times per day
Interventions/Control_2	Relvar (20 patients) Brand Name: Relvar200Ellipta Moderate-High dose: 200 micrograms per day Study Period: 24 weeks Frequency: 1 inhalation per dose, 1 time per day
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	1. Patients diagnosed with bronchial asthma according to Japanese guideline for asthma (The Asthma Prevention and Management Guideline 2015) 2. Outpatients (men and women) at least 20 years of age who can give informed consent 3. Patients who have been using ICS monotherapy for at least 4 weeks prior to Visit 1, are insufficiently or poorly controlled on ICS monotherapy, and can switch to Flutiform or Relvar 4. Patients with severe persistent asthma and whose present treatment classifies as step 2 or step 3 according to the Asthma Prevention and Management Guideline 2015 (classification of asthma severity based on the present treatment) 5. Patients who are insufficiently or poorly controlled according to the Asthma Prevention and Management Guideline 2015
Key exclusion criteria	1. Patients with evident ACO or COPD comorbidities 2. Patients with antibiotic-resistant infections, deep mycosis, or tuberculosis disease 3. Patients who have been afflicted with a respiratory infection (viral infection) within 8 weeks prior to enrollment 4. Patients with a smoking history of at least 10 pack years 5. Patients who have experienced side effects from the use of ICS, LABA or the combined medications 6. Patients who have used systemic steroids within 4 weeks prior to enrollment 7. Patients with significant heart, liver, kidney disease or other clinically significant comorbidities 8. Patients who are pregnant, breastfeeding, or plan to become pregnant during the study period 9. Other patients who are judged unsuitable for inclusion by the investigators in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Ikeda
Organization	Ikeda Clinic
Division name	Director
Zip code	751-0856
Address	3-11-2 Ichinomiyacho, Shimonoseki, Yamaguchi Prefecture, Japan Postal Code: 751-0856
TEL	083-263-3311
Email	kiikiiken@gmail.com

Public contact
Name of contact person	1st name Kenji Middle name Last name Ikeda
Organization	Increase Co., Ltd.
Division name	Clinical Development Department
Zip code	160-0022
Address	2-12-8 shinjuku, shinjuku-ku, Tokyo
TEL	03-5312-5026
Homepage URL
Email	jtsuchiya@sa-tt.co.jp

Sponsor
Institute	Ikeda Clinic
Institute
Department

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

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

IRB Contact (For public release)
Organization	goshogaya
Address	1-6-1 maiduru,chuuou-ku,fukuoka city
Tel	092-739-8525
Email	gosho_irb@yahoo.co.jp

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 01 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
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	2017 Year 11 Month 24 Day
Date of IRB	2017 Year 12 Month 14 Day
Anticipated trial start date	2018 Year 01 Month 29 Day
Last follow-up date	2020 Year 02 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 07 Month 22 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2020 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035450