UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Title of the study (Brief title)	A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Region	Japan

Condition
Condition	aspirin exacerbated respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of add on Benralizumab for uncontrolled aspirin exacerbated respiratory disease despite using therapeutic agent for asthma including Omalizumab.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	change from baseline to week 4 in Sino-Nasal Outcome Test (SNOT22) score
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients diagnosed with aspirin exacerbated pulmonary disease (AERD) by a systemic aspirin provocation test or a history of characteristic respiratory reactions upon ingestion of COX-1 inhibitors. 2)A blood eosinophil level of 150 cells or more per microliter. 3)Able to provide written, signed and dated informed consent
Key exclusion criteria	1) Previous treatment with benralizumab and mepolizumab in the past year. 2) Unable to provide written, signed and dated informed consent 3) Patients considered at risk of sinusitis and/or nasal polyp surgery during the study period 4) Patients with comorbidities (renal, hepatic, heart, mental, and malignancy etc) requiring treatment 5) Pregnancy, breast-feeding, or potential pregnancy 6) Patients considered unsuitable by the attending physician
Target sample size	20

Research contact person
Name of lead principal investigator	Masami Taniguchi
Organization	Sagamihara National Hospital
Division name	Clinical Research Center for Allergy and Rheumatology
Address	18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL	042-742-8311
Email	m-taniguchi@sagamihara-hosp.gr.jp

Public contact
Name of contact person	Yosuke Kamide
Organization	Sagamihara National Hospital
Division name	Clinical Research Center for Allergy and Rheumatology
Address	18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL	042-742-8311
Homepage URL
Email	m08702012@gunma-u.ac.jp

Sponsor
Institute	Sagamihara National Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 04 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 03 Month 12 Day
Anticipated trial start date	2018 Year 05 Month 01 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	Study design: Prospective cohort study Study duration:from 2018/5/1 to 2021/3/31 Subjects:All subjects that our hospital visited by AERD, and met the selection criteria.

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036932