UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027695 |
|---|---|
| Receipt number | R000031582 |
| Scientific Title | A non-interventional study to investigate the proportion, characteristics and treatment reality of adult patients with severe and uncontrolled severe asthma using a claims database |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2018/10/23 11:31:44 |
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Basic information
Public title
A non-interventional study to investigate the proportion, characteristics and treatment reality of adult patients with severe and uncontrolled severe asthma using a claims database
Acronym
KEIFU study
Scientific Title
A non-interventional study to investigate the proportion, characteristics and treatment reality of adult patients with severe and uncontrolled severe asthma using a claims database
Scientific Title:Acronym
KEIFU study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It may be very important for clinical decision making and drug prescription to clarify more accurately the prevalence of severe asthma and uncontrolled severe asthma. Therefore, we will focus on investigating the proportion of severe asthma or uncontrolled severe asthma in Japan.
Basic objectives2
Others
Basic objectives -Others
To investigate the proportion of patients with severe and uncontrolled severe asthma in treated asthma patients using a claims database
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Following patient proportion in treated asthma patients;
severe asthma, uncontrolled severe asthma
Key secondary outcomes
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-17 years of age and older at the index date
-Patients who had claim within 12 months prior to Index date
-Patients who had a record of asthma diagnosis 12 and more months prior to Index date
-Patients who had 4 or more "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" within 12 months prior to Index date
Key exclusion criteria
-Patients who didin't have the "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" within 6 months prior to Index date
-Patients who didin't have the "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" during the period of more than 6 months and within 12 months prior to Index date
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetaka Kouda |
Organization
Astrazeneca K.K
Division name
Medical department
Zip code
Address
3-1 Ofukacho, Osaka Kita-ku, Osaka, Granfront Osaka Tower B
TEL
06-4802-3600
Shigetaka.Kouda@astrazeneca.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Yoshimura |
Organization
Astrazeneca K.K
Division name
Medical department Evidence & Observational Research
Zip code
Address
3-1 Ofukacho, Osaka Kita-ku, Osaka, Granfront Osaka Tower B
TEL
06-4802-3600
Homepage URL
yoko.yoshimura@astrazeneca.com
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
Address
Tel
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
| 2017 | Year | 06 | Month | 14 | 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
The primary analysis set consisted of 10,579 'athma patients under treatment'.
'Athma patients under treatment' included 823 'severe asthma patients'(7.8%). The number (%) of 'uncontrolled severe asthma patients' was 267 patients (2.5%), and that of 'non-severe patients' was 9,756 (92.2%).
Compared to 'non-severe patients', 'uncontrolled severe asthma patients' had a higher frequency in asthma exacerbation and more expensive direct medical expenditure. Also, compared to 'non-severe patients', 'uncontrolled severe asthma patients' had a higher amount of use of systemic steroids.
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
| 2017 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Utilize the claims database
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031582
