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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029218
Receipt No. R000033399
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
Date of disclosure of the study information 2017/09/20
Last modified on 2018/03/23

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Basic information
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
Condition Asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

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
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

Research contact person
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

Public contact
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

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 該当なし / None

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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.

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033399

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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