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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033615
Receipt No. R000038319
Official scientific title of the study Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Date of disclosure of the study information 2018/08/03
Last modified on 2018/08/02

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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