UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052162 |
|---|---|
| Receipt number | R000058208 |
| Scientific Title | The clinical course of severe asthma patients who have achieved clinical remission. |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2025/03/13 08:30:03 |
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Basic information
Public title
The clinical course of severe asthma patients who have achieved clinical remission.
Acronym
The clinical course of severe asthma patients who have achieved clinical remission.
Scientific Title
The clinical course of severe asthma patients who have achieved clinical remission.
Scientific Title:Acronym
The clinical course of severe asthma patients who have achieved clinical remission.
Region
| Japan |
Condition
Condition
severe asthma patients
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the clinical course of severe asthma patients who have achieved remission.
Basic objectives2
Others
Basic objectives -Others
The aim of the study is to clarify the clinical course of severe asthma patients who have achieved clinical and/or biological remission and the associated factors including the use of biologic agents. To identify the characteristics of patients with remission, we also evaluate unstable severe asthma patients to compare with those with remission.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of relapse
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
subjects with severe asthma who meet all of the following criteria.
1. subjects who have been followed by pulmonologist for 3 months or more.
2. subjects who receive high dose inhaled steroids and long-activating beta stimulant (or leukotriene antagonist or theophylline) or biological products, or receive steroids systematically for half a year or more.
3. subjects who are supposed to get uncontrolled without the medication above.
Key exclusion criteria
subjects who are unable to fill questionaries.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Takahashi |
Organization
Kishiwada City Hospital
Division name
Respiratory Medicine
Zip code
596-8501
Address
1001, Kakunohara, Kishiwada-shi, Osaka
TEL
072-445-1000
kch-12@kishiwada-hospital.com
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kogo |
Organization
Kishiwada City Hospital
Division name
Respiratory Medicine
Zip code
596-8501
Address
1001, Kakunohara, Kishiwada-shi, Osaka
TEL
072-445-1000
Homepage URL
m.k.kogo2@gmail.com
Sponsor or person
Institute
N/A
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kishiwada City Hospital
Address
1001, Kakunohara, Kishiwada-shi, Osaka
Tel
072-445-1000
byouin@city.kishiwada.osaka.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
| 2023 | Year | 09 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collaborative research with Kobe City Medical Center General Hospital
Management information
Registered date
| 2023 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058208
