UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Title of the study (Brief title)	Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of efficacy and safety of benralizumab in the treatment of severe asthma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Spirometry
Key secondary outcomes	Astma Control Test(ACT), Asthma Control Questionnaire(ACQ), Asthma Quality of Life Questionnaire(AQLQ), FeNO, Objective opinion, Sputum eosinophil counts, Chest X-ray, Chest CT, Respiratory resistance test, Oral corticosteroid dose, Absence of unexpected visit and hospitalization due to asthma exacerbation, Clinical examination, Sinus CT, Safety

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	Benralizumab is given subcutaneously
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	1. Patients receiving oral corticosteroid daily 2. Patients with increasing of corticosteroid or needing corticosteroid temporalily at least twice a year due to asthma exacerbation 3. Patients with ACT<25 or ACQ>0
Key exclusion criteria	1. Patients with intention to refuse to participate in this research. 2.Patients with a history of hypersensitivity to this drug and the ingredients of this drug. 3. Patients under 20 years old. 4. Patients who may be pregnant. 5. Patients with breastfeeding 6. Patients deemed ineligible by the attending physicians for various reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Tachiwada
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1,Iseigaoka,Yahata-nishi-ku, Kitakyushu,Fukuoka,807-8555, Japan
TEL	093-691-7453
Email	kokyu2@mbox.med.uoeh-u.ac.jp

Public contact
Name of contact person	Takashi Tachiwada
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1,Iseigaoka,Yahata-nishi-ku, Kitakyushu,Fukuoka,807-8555, Japan
TEL	093-691-7453
Homepage URL
Email	kokyu2@mbox.med.uoeh-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 08 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 08 Month 02 Day
Last modified on	2018 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038319