UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045021 |
|---|---|
| Receipt number | R000051080 |
| Scientific Title | A multicenter retrospective observational study of effectiveness of mepolizumab in patients with severe eosinophilic asthma and comorbidities in Japan (J-Real-Mepo) |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2025/02/04 11:41:11 |
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Basic information
Public title
A multicenter retrospective observational study of effectiveness of mepolizumab in patients with severe eosinophilic asthma and comorbidities in Japan (J-Real-Mepo)
Acronym
J-Real-Mepo
Scientific Title
A multicenter retrospective observational study of effectiveness of mepolizumab in patients with severe eosinophilic asthma and comorbidities in Japan (J-Real-Mepo)
Scientific Title:Acronym
J-Real-Mepo
Region
| Japan |
Condition
Condition
Severe asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study may clarify the following research questions by examining the effectiveness of mepolizumab in the real-world setting in severe asthma patients with various backgrounds, such as a smoking history of 10 pack-year or more and no airways reversibility, and it is expected to bridge the gap between the clinical trials reported to date and the actual treatment in clinical practice.
1) To what extent does mepolizumab reduce the frequency of asthma exacerbations and use of systemic steroids for patients with severe asthma in the real-world setting?
2) Are mepolizumab efficacious in severe asthma patients with a smoking history of 10 pack-years or more?
3) Can we predict the effectiveness of mepolizumab for asthma exacerbations by patient background factors including comorbidities and biomarkers?
4) Does mepolizumab improve sinonasal computed tomography (CT)findings presenting with eosinophilic chronic rhinosinusitis(ECRS) in severe asthma patients?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Frequency of clinically significant asthma exacerbations from the first day of mepolizumab to Week 12-52
2) Changes in the use of systemic steroids from the date of the first dose of mepolizumab to a maximum of 52 weeks later
Key secondary outcomes
1) Time course of ACQ, ACT, AHQ, FEV1, eosinophil counts, basophil counts, neutrophil counts, lymphocyte counts, FeNO, biomarkers, sinonasal CT/MRI scores, and nasal manifestations from the starting day of mepolizumab treatment to up to 52 weeks.
2) ~ 6) Associations between baseline and clinically significant asthma exacerbations, ACQ, ACT, AHQ, FEV1, and sinonasal CT/MRI scores during mepolizumab treatment:
2) History of smoking >=10 pack-year/<
3) Airway reversible positive/negative
4) Comorbidities
5) Biomarkers
6) Patient background factors (items in Tables 3, 4, and 5)
7) Relationship between change in ACQ, ACT, FEV1, frequency of exacerbations, biomarkers (eosinophil count, ECP), or time points and subsequent improvement in each clinically significant asthma exacerbation, ACQ, ACT, or FEV1 after 4 and 12 weeks of mepolizumab treatment.
8) Post-discontinuation treatment patterns in patients who discontinued mepolizumab.
9) Correlation between sinonasal CT findings and improvement in asthma exacerbations.
10) Effectiveness of mepolizumab on eosinophilic otitis media.
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
1) Age 20 or older
2) Diagnosed as severe asthma at the first dose of mepolizumab
3) Have results of measurement of peripheral blood eosinophil count at the first dose of mepolizumab
4) The number of with asthma exacerbations* from 12 weeks prior to the first mepolizumab dose to the time of the first mepolizumab dose is known
5) Previous mepolizumab treatment for >12 weeks
6) It is possible to obtain written informed consent for participation in this study.
*; The definition of asthma exacerbation is as follows.
a. Systemic steroids, including oral and IV products, administered for 3 days or more in association with asthma exacerbation
(Day of onset; Day of first administration of systemic steroids including oral and IV formulations associated with asthma exacerbation)
b. In patients who regularly use oral corticosteroids, at least twice the usual dose for at least 3 days
(Day of onset; day when oral steroids at least twice the daily dose were started for at least 3 days with asthma exacerbation)
c. Asthma exacerbation requiring visit to the emergency department or hospitalization
(Day of onset; date of emergency department visit or hospitalization associated with asthma exacerbation)
Key exclusion criteria
1) There is a significant lack of information recorded in the medical record.
2) Some or all mepolizumab treatments were performed outside the study site
3) Other than the above, the principal investigator subinvestigator judged the participation in the study to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
1738605,2-11-1 Kaga, Itabashi-ku, Tokyo Japan
TEL
81-3-3964-8351
nagaseh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
1738605, 2-11-1 Kaga, Itabashi-ku, Tokyo Japan
TEL
81-3-3964-8351
Homepage URL
nagaseh@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan
Tel
03-3964-7256
turb-office@teikyo-u.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
東京女子医科大学病院（東京）、東京医科歯科大学医学部附属病院（東京）、独立行政法人国立病院機構東京病院（東京）、日本大学医学部附属板橋病院（東京）、慶應義塾大学病院（東京）、 国立国際医療研究センター病院（東京）、昭和大学病院（東京）、順天堂大学医学部附属順天堂医院（東京）、新潟大学医歯学総合病院（新潟）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.teikyo-u.ac.jp/affiliate/ethic_committee
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39848869/
Number of participants that the trial has enrolled
201
Results
Please refer to the article in HP shown above.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 03 | Day |
Baseline Characteristics
Please refer to the article in HP shown above.
Participant flow
Please refer to the article in HP shown above.
Adverse events
Please refer to the article in HP shown above.
Outcome measures
Please refer to the article in HP shown above.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051080
