UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting - A Cross-sectional Study of Adult Asthma Patients in Japan
Title of the study (Brief title)	Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting - A Cross-sectional Study of Adult Asthma Patients in Japan (ACQUIRE-2)
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the proportion of adult asthma patients receiving continued treatment from physician in Japan in each asthma control status defined by JGL 2015 ("poorly-controlled," "insufficiently-controlled," and "well-controlled")
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary variable is status of asthma control in each patient.
Key secondary outcomes	1.Asthma symptoms (e.g., intensity, frequency, and limitations on activities, etc.) 2.Use of drugs for the treatment of asthma 3.Asthma control during the past 1 week 4.Asthma control status during the past 1 month 5.QOL 6.Use of drugs for asthma attack and emotional feelings

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Provided written consent before starting any procedure specified in the study protocol 2.Aged 20 years or older at the time of providing the consent 3.Receiving treatment for asthma as an outpatient at the time of providing the consent 4.Physician definitive diagnosis of asthma at least 1 year before providing the consent 5.Started to receive treatment with at least 1 of the asthma drugs at least 1 year before providing the consent
Key exclusion criteria	1.Enrolled in this study in the past 2.Assessed by the Investigator to require additional treatment due to worsening of asthma symptoms at the time of providing the consent 3.Scheduled to be hospitalized within 2 weeks after providing the consent due to asthma or any other disease 4.Participating in another interventional study such as a clinical study at the time of providing the consent 5.Considered by the Investigator as not appropriate for enrollment in this study due to inability to adhere to the procedures, limitations, and requirements of this study including answering and returning the questionnaires, etc.
Target sample size	1100

Research contact person
Name of lead principal investigator	AstraZeneca K.K. Medical Gastrointestinal Respiratory / Inflammation / Autoimmune
Organization	AstraZeneca K.K.
Division name	Gastrointestinal Respiratory/Inflammation / Autoimmune Medical
Address	3-1, Ofukacho, Kita-ku, Osaka
TEL	06-4802-3600
Email	Tatsunori.Jinnai@astrazeneca.com

Public contact
Name of contact person	Mitsuru Shimomura
Organization	CMIC HOLDINGS CO., Ltd.
Division name	Business Incubation Unit Business Promotion Dept.
Address	1-1-1, Shibaura, Minato-ku, Tokyo
TEL	+81-3-6779-8013
Homepage URL
Email	acquire2-help@cmic.co.jp

Sponsor
Institute	AstraZeneca K.K.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	YES
Study ID_1	NCT02640742
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 13 Day
Anticipated trial start date	2015 Year 12 Month 17 Day
Last follow-up date	2016 Year 06 Month 17 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	- Study Design: This is a cross-sectional study in 1100 adult asthma patients receiving continued treatment by physician in Japan. - Patients Registration : Investigators of this study will record in the patient screening list, etc. the information of patients screened for enrollment in this study. Investigators will conduct the following: 1. Obtain written consent from candidate patients before performing any procedure related to the study. 2. Confirm that patients meet the inclusion criteria and not the exclusion criteria. 3. Transmit the FAX document to the registration center. 4. Confirm the document replied from the registration center.

Management information
Registered date	2015 Year 12 Month 17 Day
Last modified on	2016 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023389