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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040859
Receipt No. R000046621
Scientific Title Activation status of eosinophils in severe asthma patients treated with biologics
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/22

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Basic information
Public title Activation status of eosinophils in severe asthma patients treated with biologics
Acronym ACT study
Scientific Title Activation status of eosinophils in severe asthma patients treated with biologics
Scientific Title:Acronym ACT study
Region
Japan

Condition
Condition Severe asthma
Mild asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the variable activation status of circulating eosinophils in severe asthma and mild asthma by performing RNA-seq in whole blood cells and purified blood eosinophils. Then, to evaluate the phenotypic alterations of blood eosinophils after treatment with the biologics mepolizumab, omalizumab, or dupilumab in the same way.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Elucidation of the phenotypic heterogeneity of circulating eosinophils in severe asthma and mild asthma by performing RNA-seq in whole blood cells and purified blood eosinophils.
Key secondary outcomes Subsequent evaluation of the phenotypic alterations of blood eosinophils after treatment with the biologics mepolizumab, omalizumab, and dupilumab.

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

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria for all participants
1. All participants are over 20 years old and are required to have received a clinical diagnosis of eosinophilic asthma by a physician.
2. Informed consents from all participants are obtained.

Specific inclusion criteria for each group
Participant group 1 (N=5).
1. Mild eosinophilic asthma who have an elevated peripheral blood eosinophil count of 150 cells per uL or more at Visit 1

Participant group 2 (N=5 for each treatment, total N=15)
1. Severe eosinophilic asthma patients already being on the treatment of any biologic (mepolizumab, omalizumab, or dupilumab). These patients must be taking a biologic for at least 4 months with a good clinical response using GETE score.

2. These patients must have had at least one asthma exacerbation in the previous year before starting biologics, that required treatments with systemic glucocorticoids or some biologics while they were receiving treatment with high dose inhaled corticosteroid (ICS) with additional controllers.

Participant group 3 (N=3 for each biologic, total N=9),
1. Severe asthma patients who are going to take mepolizumab, omalizumab, or dupilumab for the first time.
2. These patients have an elevated peripheral blood eosinophil count of 150 cells per uL or more at Visit 1.
3. These patients must have had at least one asthma exacerbation in the previous year that required treatments with systemic glucocorticoids or some biologics while they were receiving treatment with high dose inhaled corticosteroid (ICS) with additional controllers.
4. In the cases of severe asthma patients who have already been treated with some biologics, these patients never had a good asthma control with the currently used biologic.
5. Based on the clinical practice, the participation in this study should be considered after a new biologic was determined based on agreement between the attending physician and the patient. Only if consent can be obtained thereafter.
Key exclusion criteria Exclusion criteria for all participant group
1. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
3. Liver Disease: Known, pre-existing, unstable liver disease.
4. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
5. Other Concurrent Medical Conditions: Subjects who have known, pre-existing,
clinically significant endocrine, autoimmune, metabolic, neurological, renal,
gastrointestinal, hepatic, haematological or any other system abnormalities that
are uncontrolled with standard treatment.
6. Eosinophilic Diseases: Subjects with other conditions that could lead to elevated
eosinophils such as hyper-eosinophilic syndrome, Churg-Strauss syndrome, or eosinophilic esophagitis.
7. Pregnancy: Subjects who are pregnant or breastfeeding.

Specific exclusion criteria for each group
Participant group 3 (N = 3 for each biologic, total N=9),
1. Participants who have received any biologics (mepolizumab, omalizumab, benralizumab, or dupilumab) within 56 days before Visit 1.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Matsuyama
Organization University of Tsukuba Hospital
Division name Department of respiratory medicine
Zip code 305-8575
Address 1-1-1, Tennoudai, Tsukuba, Ibaraki, Japan
TEL 029-853-3144
Email mmatsuyama@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Matsuyama
Organization University of Tsukuba Hospital
Division name Department of respiratory medicine
Zip code 305-8575
Address 1-1-1, Tennoudai, Tsukuba, Ibaraki, Japan
TEL 029-853-3144
Homepage URL
Email mmatsuyama@md.tsukuba.ac.jp

Sponsor
Institute Department of respiratory medicine, University of Tsukuba Hospital
Institute
Department

Funding Source
Organization GlaxoSmithKline, Inc. (GSK)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization UK

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

IRB Contact (For public release)
Organization Tsukuba Clinical Research & Development Organization
Address 2-1-1, Amakubo, Tsukuba, Ibaraki, Japan, 305-8576
Tel 029-853-3914
Email t-credo.adm@un.tsukuba.ac.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
2020 Year 07 Month 01 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
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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 02 Day
Date of IRB
2020 Year 04 Month 02 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To elucidate the variable activation status of circulating eosinophils in severe asthma and mild asthma by performing RNA-seq in whole blood cells and purified blood eosinophils. Then, to evaluate the phenotypic alterations of blood eosinophils after treatment with the biologics mepolizumab, omalizumab, or dupilumab in the same way.

Management information
Registered date
2020 Year 06 Month 22 Day
Last modified on
2020 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046621

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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