UMIN-CTR Clinical Trial

Public title

A Study on the Perception of Symptoms and Burden in Asthma Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire

Acronym

A Study on the Perception of Symptoms and Burden in Asthma Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire

Scientific Title

A Study on the Perception of Symptoms and Burden in Asthma Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire

Scientific Title:Acronym

A Study on the Perception of Symptoms and Burden in Asthma Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire

Region

Japan

Condition

Asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To consider the perception of asthma symptoms by Pure Recall and Assisted Recall and to highlight actual situation for asthma patients on consultation in Japan

Basic objectives2

Others

Basic objectives -Others

Survey

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Following items for all responded data among whole 788 survey participants:
Numbers and proportions of patients with perceived symptoms (patients with perceived symptoms by Pure Recall, patients with perceived symptoms by Assisted Recall, patients without perception of symptoms) and confidence intervals for each.

Key secondary outcomes

1.Numbers and proportions of patients on each of the following minor item answer selections by type of perception of symptoms (Pure Recall / Assisted Recall) on answered data for all detailed-survey participants with perceived symptoms among the survey participants:
<Items related to screening questionnaires>
- Demographic background
- Situation of consultation
- Use of oral steroid, etc.
<Items related to detailed survey>
- Limit by symptoms
- Physical and/or spiritual burden by symptoms
- Impressive symptoms
- Start event of symptoms
- Situation of symptoms occurrence
- Influence to daily life by symptoms
- Mood when symptoms occurred
- Devise to repress symptoms
- Hope to improve symptoms
- Awareness to asthma
- Use of medicine for cure
- Medical history for asthma
- Living situation with family members
- Self payment rate for health care costs, etc.
<Symptoms and situations to specific category>
- Symptoms and situations related to sleeping and event at night, etc.

2. Numbers and proportions of patients on each of the following minor item answer selections by presence / absence of sleep-relating events on answered data for all detailed-survey participants with perceived symptoms among the survey participants:
<Items related to screening questionnaires>
- Demographic background
- Situation of consultation
- Use of oral steroid, etc.
<Items related to detailed survey>
(common to 1. above)

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Participated patients who answered all screening questionnaires on "Patients Survey on Asthma Patients"

Key exclusion criteria

None

Target sample size

788

Name of lead principal investigator

1st name
Middle name
Last name	Astrazeneca K.K Medical department

Organization

AstraZeneca K.K.

Division name

Medical Department

Zip code

Address

3-1, Ofuka-cho, Kita-ku Osaka Grand Front Osaka Tower B

TEL

06-4802-3600

Email

Miwa.Nagasawa@astrazeneca.com

Name of contact person

1st name
Middle name
Last name	Miwa Nagasawa

Organization

AstraZeneca K.K.

Division name

Medical Department

Zip code

Address

3-1, Ofuka-cho, Kita-ku Osaka Grand Front Osaka Tower B

TEL

06-7711-4658

Homepage URL

Email

Miwa.Nagasawa@astrazeneca.com

Institute

AstraZeneca K.K.

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

該当なし / None

Date of disclosure of the study information

2017

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.iyaku-j.com/iyakuj/system/M2-1/summary_viewer.php?trgid=34157

Number of participants that the trial has enrolled

Results

45.8% of the asthma patients were conscious of the symptom when a question (pure recall type) was simply asked whether a symptom exists.

Among the patients who did not perceive the symptom by a pure recall question, 68.3% (which is 37.6% of total patients) is aware of the symptoms by a further question (assisted recall type) that contains information leading to a specific symptoms, situations and triggers.
Combining the former patients who percieve the symptom by a pure recall, 83.4% of total patiens peceives the symptoms.

72.0% of the patinets who perceive the symptoms responded to have some influence or trouble in sleep due to symptoms.

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

Main results already published

Date of protocol fixation

2017

Year

08

Month

30

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2017

Year

10

Month

06

Day

Date analysis concluded

2017

Year

10

Month

31

Day

Other related information

Study Design: Non-interventional, cross-sectional and retrospective observational study using an existing internet-based questionnaire

Data Source: Answers on internet-based questionnaire "Patient Survey on Asthma Patients" conducted by MCI (Medical Collective Intelligence) Co. Ltd.

Target Population: Patients living in Japan who is older than 16 years old, is diagnosed as asthma, and have an irregular or regular medical consultation in the past one year.

Registered date

2017

Year

09

Month

20

Day

Last modified on

2018

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033399