UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shigetaka Kouda
Organization	Astrazeneca K.K
Division name	Medical department
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	Yoko Yoshimura
Organization	Astrazeneca K.K
Division name	Medical department Evidence & Observational Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000031582