UMIN-CTR Clinical Trial

Public title

Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting - A Cross-sectional Study of Adult Asthma Patients in Japan

Acronym

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)

Scientific Title

Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting - A Cross-sectional Study of Adult Asthma Patients in Japan

Scientific Title:Acronym

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

Asthma

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	AstraZeneca K.K. Medical Gastrointestinal Respiratory / Inflammation / Autoimmune

Organization

AstraZeneca K.K.

Division name

Gastrointestinal Respiratory/Inflammation / Autoimmune Medical

Zip code

Address

3-1, Ofukacho, Kita-ku, Osaka

TEL

06-4802-3600

Email

Tatsunori.Jinnai@astrazeneca.com

Name of contact person

1st name
Middle name
Last name	Mitsuru Shimomura

Organization

CMIC HOLDINGS CO., Ltd.

Division name

Business Incubation Unit Business Promotion Dept.

Zip code

Address

1-1-1, Shibaura, Minato-ku, Tokyo

TEL

+81-3-6779-8013

Homepage URL

Email

acquire2-help@cmic.co.jp

Institute

AstraZeneca K.K.

Institute

Department

Personal name

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2015

Year

12

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

11

Month

13

Day

Date of IRB

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

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.

Registered date

2015

Year

12

Month

17

Day

Last modified on

2016

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023389