UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043238 |
|---|---|
| Receipt number | R000049270 |
| Scientific Title | KOFU study A cross-sectional web survey study on biologics benefit in view of severe asthma patients |
| Date of disclosure of the study information | 2021/02/03 |
| Last modified on | 2021/08/05 14:30:28 |
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Basic information
Public title
KOFU study
A cross-sectional web survey study on biologics benefit in view of severe asthma patients
Acronym
KOFU study
A cross-sectional web survey study on biologics benefit in view of severe asthma patients
Scientific Title
KOFU study
A cross-sectional web survey study on biologics benefit in view of severe asthma patients
Scientific Title:Acronym
KOFU study
A cross-sectional web survey study on biologics benefit in view of severe asthma patients
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate patients satisfaction, subjective impression, and patients impression for current treatment in severe asthma patients with biologics (BIO) treatment, and those without BIO treatment and previously recommended to use BIO treatment
Basic objectives2
Others
Basic objectives -Others
To investigate explanation process, patients thought, acceptance and refusal of BIO treatment , background of BIO discontinuation, and communication with primary doctor and recognition of severity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate patients satisfaction, subjective impression for asthma and patients impression for current treatment in severe asthma patients with biologics (BIO) treatment, and severe asthma patients without BIO treatment and previously recommended to use BIO treatment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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) Electric informed consent on the web-site
2) Females and males aged 20 years or older at time of enrollment
3) History of physician-diagnosed asthma requiring treatment at one year or more prior to enrolment
4) Be continuously treated by daily ICS or ICS/LABA to enrolment
5) Severe asthma patients treated by high dose ICS plus additional treatment, OCS or biologics
Key exclusion criteria
1) Patients who cannot complete all questions of this survey's questionnaire
2) Patients who answered questions in less than 2 seconds per question in average
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Sugaya |
Organization
AstraZeneca K.K.
Division name
Medical
Zip code
1000005
Address
9F Marunouchi Trust Tower Main Building, 1-8-3 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6268-2600
satoko.sugaya@astrazeneca.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Mebix, Inc.
Division name
Devision of research promotion
Zip code
1050001
Address
10F Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-4362-4500
Homepage URL
fujimoto@mebix.co.jp
Sponsor or person
Institute
AstraZeneca K.K.
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Takahashi Clinic
Address
5-1-31 Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.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 | 02 | Month | 03 | 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
| 2021 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049270
| 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 |
