UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054896 |
|---|---|
| Receipt number | R000062053 |
| Scientific Title | achievement rate and predictive factors of clinical remission in patients with severe asthma under biologics treatment |
| Date of disclosure of the study information | 2024/07/06 |
| Last modified on | 2026/01/05 18:39:43 |
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Basic information
Public title
achievement rate and predictive factors of clinical remission in patients with severe asthma under biologics treatment
Acronym
clinical remission in patients with severe asthma under biologics
Scientific Title
achievement rate and predictive factors of clinical remission in patients with severe asthma under biologics treatment
Scientific Title:Acronym
clinical remission in patients with severe asthma under biologics
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess clinical remission in patients with severe asthma under biologics
Basic objectives2
Others
Basic objectives -Others
to assess predictive factors of clinical remission
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
achievement rate of clinical remission in patients with severe asthma one year after administration of biologics
Key secondary outcomes
(1) difference in clinical characteristics and disease phenotype in between patients with achievement of clinical remission and those without
(2) difference in clinical remission among biologics
(3) achievement rate of clinical remission in patients with severe asthma two years after administration of biologics
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) adult patients equal or more than 20 years
(2) patients who had been diagnosed as asthma or cough variant asthma from August 1 2013 to April 30 2024
(3) patients who had undergone biologics treatment for asthma or cough variant asthma
Key exclusion criteria
patients who reject to enrollment of study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528538216
tomokot@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528538216
Homepage URL
tomokot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Nagoya City 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
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
0528525511
tomokot@med.nagoya-cu.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
| 2024 | Year | 07 | Month | 06 | 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
87
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062053
