UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045636 |
|---|---|
| Receipt number | R000052101 |
| Scientific Title | Comparison of efficacy between triple and combination therapy in asthma using visual analog scale |
| Date of disclosure of the study information | 2021/10/02 |
| Last modified on | 2023/02/27 17:56:47 |
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Basic information
Public title
Usefulness of visual analog scale for efficacy of medicines for asthma: Comparison between ICS/LABA/LAMA triple and ICS/LABA combination therapy - a retrospective cohort study
Acronym
Comparison of efficacy between triple and combination therapy in asthma using visual analog scale
Scientific Title
Comparison of efficacy between triple and combination therapy in asthma using visual analog scale
Scientific Title:Acronym
Comparison of efficacy between SITT and dual therapy in asthma using VAS
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of visual analog scale in asthma-control levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of visual analog scale in asthma-control levels 4 weeks after treatment
Key secondary outcomes
Comparison of asthma-control levels by visual analog scale between triple and dual therapy e 4 weeks after treatment
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. asthma who attended to Fujiki internal and surgery clinic
2. receive triple or ICS/LABA dual therapy
Key exclusion criteria
1. Not evaluated asthma-control levels by visual analog scale
2. No evaluated asthma-control levels by asthma control test
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume
TEL
0942317560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume
TEL
0942317560
Homepage URL
https://www.kurume-u.ac.jp/site/aro/
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
Kurume University
Address
67 Asahimachi, Kurume
Tel
0942353311
I_rinri@kurume-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
| 2021 | Year | 10 | Month | 02 | 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
308
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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 01 | Day |
Other
Other related information
a retrospective cohort study
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052101
