UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052207 |
|---|---|
| Receipt number | R000059578 |
| Scientific Title | The study of the impact of changes in surface antigens on eosinophils after treatment in patients with asthma |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/03/15 13:00:46 |
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Basic information
Public title
The study of the impact of changes in surface antigens on eosinophils after treatment in patients with asthma
Acronym
The study of eosinophils and asthma
Scientific Title
The study of the impact of changes in surface antigens on eosinophils after treatment in patients with asthma
Scientific Title:Acronym
The study of the surface antigens on eosinophils and asthma
Region
| Japan |
Condition
Condition
Patients with asthma and asthma suspicion
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate whether the low CD62- and CD34-positive eosinophils at pre-treatment and early improvement of CD62- and CD34-positive eosinophils after treatment can be estimable biomarkers of clinical remission of asthma.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The low CD62- and CD34-positive eosinophils at pre-treatment and early improvement of CD62- and CD34-positive eosinophils after treatment are estimable biomarkers of clinical remission of asthma.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
asthma controllers
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with asthma and asthma suspicion
Key exclusion criteria
1) current and ex-heavy smokers (>10pack-year)
2) Immunosuppressive patients with active cancer and HIV infections
3) History of patients with lung resections
4) During severe or fatal asthma exacerbations
5) Other chronic respiratory diseases
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Department of Medicine, Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
kawayama_tomotaka@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoataka |
| Middle name | |
| Last name | Kawayama |
Organization
Department of Medicine, Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
Homepage URL
http://kurume-ichinaika.com/
kawayama_tomotaka@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Clinical Research Center
Address
67 Asahi-machi, Kurume
Tel
0942317200
http://www.hosp.kurume-u.ac.jp/clinical-trial/index.html
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
| 2023 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059578
