UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039499 |
|---|---|
| Receipt number | R000045043 |
| Scientific Title | Comparison of the respiratory function in bronchial asthma subtypes classified by impulse oscillometry system |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2023/08/22 23:07:47 |
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Basic information
Public title
Comparison of the respiratory function in bronchial asthma subtypes classified by impulse oscillometry system
Acronym
Comparison of the respiratory function in bronchial asthma subtypes classified by impulse oscillometry system
Scientific Title
Comparison of the respiratory function in bronchial asthma subtypes classified by impulse oscillometry system
Scientific Title:Acronym
Comparison of the respiratory function in bronchial asthma subtypes classified by impulse oscillometry system
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of inhaled corticosteroid and respiratory function in bronchial asthma subtypes
Basic objectives2
Others
Basic objectives -Others
usefulness of impulse oscillometry
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma health questionnaire(AHQ)-Japan score
Key secondary outcomes
Spirometry
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
Patients who were diagnosed with bronchial asthma
Key exclusion criteria
Patients who were not evaluated the therapeutic effect with AHQ score
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugawara |
Organization
Sugawara internal medicine and respiratory clinic
Division name
respiratory medicine
Zip code
053-0821
Address
Shirakabacho 1-18-9, Tmakomai, Hokkaido
TEL
0144-76-7772
sugawara-clinic@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugawara |
Organization
Sugawara internal medicine and respiratory clinic
Division name
respiratory medicine
Zip code
053-0821
Address
Shirakabacho 1-18-9, Tmakomai, Hokkaido
TEL
0144-76-7772
Homepage URL
sugawara-clinic@cb3.so-net.ne.jp
Sponsor or person
Institute
Sugawara internal medicine and respiratory clinic
Institute
Department
Personal name
Funding Source
Organization
Sugawara internal medicine and respiratory clinic
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
the institutional ethical committee of Sapporo Medical Association
Address
Chuoku Oodori Nishi 19-1-1, Sapporo
Tel
011-611-4181
chiken@spmed.or.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
| 2020 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 22 | Day |
Other
Other related information
Retrospective observational study on evaluation of inhaled corticosteroid in patients with bronchial asthma subtypes
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045043
| Research Plan | |
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| 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 |
