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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027695
Receipt No. 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

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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
Email 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
Email yoko.yoshimura@astrazeneca.com

Sponsor
Institute Astrazeneca K.K
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031582

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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