UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051699 |
|---|---|
| Receipt number | R000058933 |
| Scientific Title | Study on phenotype transition from non-elderly asthma to elderly asthma |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/24 12:49:56 |
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Basic information
Public title
Study on phenotype transition from non-elderly asthma to elderly asthma
Acronym
Study on phenotype transition from non-elderly asthma to elderly asthma
Scientific Title
Study on phenotype transition from non-elderly asthma to elderly asthma
Scientific Title:Acronym
Study on phenotype transition from non-elderly asthma to elderly asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the phenotype transition from non-elderly to elderly asthma.
Basic objectives2
Others
Basic objectives -Others
phenotype transition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The phenotype transition pattern of non-elderly to elderly asthma
Key secondary outcomes
Factors related to phenotype transition pattern
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. asthma patients aged 65 years or older visiting the study institutions
2. asthma patients who have had asthma for more than 1 year
3. patients with the peripheral blood eosinophil count data taken before 65 years of age
4. patients with the data of %FEV1 taken before 65 years of age
Key exclusion criteria
1. patients with chronic respiratory diseases other than asthma and COPD
2. patients with a history of surgery, congenital diseases, or mental disorders that may affect pulmonary function tests
3. patients with hematologic or autoimmune diseases that may affect peripheral blood eosinophil counts
4. patients with mental disorders that may affect the asthma questionnaires
5. patients with hematologic, infectious, autoimmune, malignant, or inflammatory diseases that may affect the serum biomarkers
6. patients who are judged to be inappropriate to participate in this study by primary physicion
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585, Japan
TEL
042-491-2111
fueta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585, Japan
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Enviromental Restoration and Conversation Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Mito Medical Center
National Hospital Organization Ibarakihigashi National Hospital
National Hospital Organization Tokyo Medical Center
National Hospital Organization Disaster Medical Center
National Hospital Organization Sagamihara Hospital
National Hospital Organization Nagoya Medical Center
National Hospital Organization Kanazawa Medical Center
National Hospital Organization Wakayama National Hospital
National Hospital Organization Kinki-chuo Chest Medical Center
National Hospital Organization Osaka Toneyama Medical Center
National Hospital Organization Nara Medical Center
National Hospital Organization Minami-Okayama Medical Center
National Hospital Organization Kochi National Hospital
National Hospital Organization Fukuoka National Hospital
National Hospital Organization Fukuoka-higashi Medical Center
National Hospital Organization Okinawa National Hospital
National Hospital Organization Osaka National Hospital
National Center for Global Health and Medicine
National Hospital Organization Ehime Medical Center
Zenbe
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585, Japan
Tel
042-491-2111
fueta-tky@umin.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
| 2023 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information (history, comorbidity, treatment, symptoms)
Pulmonary function test
Forced oscillation technique
Total and specific IgE
Airway inflammation markers
Management information
Registered date
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
