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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045636
Receipt No. 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 2021/10/01

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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
Email 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/
Email kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

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
Email 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
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
2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information a retrospective cohort study

Management information
Registered date
2021 Year 10 Month 01 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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