UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030674 |
|---|---|
| Receipt number | R000034398 |
| Scientific Title | Examining the role of serum periostin as a prognostic marker of asthma |
| Date of disclosure of the study information | 2018/01/11 |
| Last modified on | 2023/01/08 10:00:29 |
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Basic information
Public title
Examining the role of serum periostin as a
prognostic marker of asthma
Acronym
test for serum periostin as a
prognostic marker of asthma
Scientific Title
Examining the role of serum periostin as a
prognostic marker of asthma
Scientific Title:Acronym
test for serum periostin as a
prognostic marker of asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify associations between baseline serum periostin levels and later treatment steps or
asthma control in patients who were enrolled in KiHAC multicenter study.
Basic objectives2
Others
Basic objectives -Others
To clarify associations between baseline blood eosinophil counts and later treatment steps or asthma control in patients who were enrolled in KiHAC multicenter study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between baseline serum periostin levels and
1) later treatment steps including the use of biologics
2) follow-up ratio and asthma control
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in KiHAC multicenter study
Key exclusion criteria
Patients who expressed a denial of secondary use to other research.
Target sample size
217
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
606-8511
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Hisako Matsumoto |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
606-8511
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3830
Homepage URL
hmatsumo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
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
Kenkyu Suishin
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
Tel
075-751-4899
trans@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
Allergol Int . 2021 Apr;70(2):252-254. doi: 10.1016/j.alit.2020.10.006. Epub 2020 Nov 18.
Number of participants that the trial has enrolled
78
Results
High serum periostin levels at baseline may predict future requirement for highly intensive asthma treatment for type-2 inflammation, i.e., the need for increasing high dose ICS, SCS use or omalizumab.
In "Assessment of serum periostin level as a predictor of requirement forintensive treatment for type-2 inflammation in asthmatics in future: A follow-up study of the KiHAC cohort".
Results date posted
| 2021 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see
Allergol Int
. 2021 Apr;70(2):252-254. doi: 10.1016/j.alit.2020.10.006. Epub 2020 Nov 18.
Participant flow
Please see
Allergol Int
. 2021 Apr;70(2):252-254. doi: 10.1016/j.alit.2020.10.006. Epub 2020 Nov 18.
Adverse events
none
Outcome measures
Please see
Allergol Int
. 2021 Apr;70(2):252-254. doi: 10.1016/j.alit.2020.10.006. Epub 2020 Nov 18.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
retrospective observation study
Management information
Registered date
| 2018 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034398
