UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040859 |
|---|---|
| Receipt number | 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 | 2023/12/08 18:14:38 |
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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
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
mmatsuyama@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of respiratory medicine, University of Tsukuba Hospital
Institute
Department
Personal name
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
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
27
Results
We evaluated the variation in gene expression profiles of peripheral blood eosinophils before and after starting treatment with mepolizumab. The expression of genes associated with IL-5/IL-5R signaling was decreased in eosinophils of patients treated with mepolizumab compared to that before starting mepolizumab. In contrast, genes particularly associated with type 1 eosinophils were upregulated after treatment with mepolizumab.
Results date posted
| 2023 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-seven cases were actually enrolled.
Group 1 (mild asthma): 6 cases
Group 2 (severe asthma on treatment with biologics): 13 cases
Group 3 (severe asthma before treatment with new biologics): 8 cases
Following the protocol, the following number of cases were included in the analysis after excluding cases with eosinophil counts less than 150 in the actual sample.
Group 1 (mild asthma): 5 cases
Group 2 (severe asthma on treatment with biologic): 12 cases
Group 3 (severe asthma before treatment with new biologics): 7 cases
Participant flow
Adverse events
Nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
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
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046621
