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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034210
Receipt No. R000038998
Scientific Title A Study on Symptoms, Impairment, and Treatment Status of COPD Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire (DREAM COPD study)
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/20

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Basic information
Public title A Study on Symptoms, Impairment, and Treatment Status of COPD Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire (DREAM COPD study)
Acronym A Study on Symptoms, Impairment, and Treatment Status of COPD Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire (DREAM COPD study)
Scientific Title A Study on Symptoms, Impairment, and Treatment Status of COPD Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire (DREAM COPD study)
Scientific Title:Acronym A Study on Symptoms, Impairment, and Treatment Status of COPD Patients in Japan: A Retrospective Analysis of an Existing Internet-Based Questionnaire (DREAM COPD study)
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the situation of the influence(burden) in daily life in regard to the presence of COPD-related symptoms and the time of occurrence in the subjects of this study
Basic objectives2 Others
Basic objectives -Others A retrospective analysis of internet-based questionnaire
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the presence of COPD-related symptoms and the time of occurrence in the subjects of this study.
Percentage of patients who responded that COPD-related symptoms are impairing with daily life are shown for each occurrence time zone.
Key secondary outcomes For each treatment situation, describe the following items.
1)The presence of COPD-related symptoms.
2)The presence of burden in daily life.
3)Explanatory contents that the doctor provided to the patient at the time of diagnosis.
4)Presence of setting of treatment goal between physician and patient.

Base
Study type Others,meta-analysis etc

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)40 years old and over.
2)Those who have a diagnosis history of COPD, emphysema or chronic bronchitis.
3)Those who answered to all survey items.
Key exclusion criteria Those who have a diagnosis history of asthma.
Target sample size 456

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsunori Jinnai
Organization AstraZeneca K.K.
Division name Evidence & Observational Reseach Medical
Zip code
Address Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka
TEL 06-7711-3714
Email Tatsunori.Jinnai@astrazeneca.com

Public contact
Name of contact person
1st name
Middle name
Last name Shigetoshi Kageyama
Organization EP-CRSU Co.,Ltd
Division name Clinical Research Headquarters
Zip code
Address Acropolis TOKYO Bldg.,6-29 Shinogawamachi, Shinjuku-ku,Tokyo
TEL 03-6759-9904
Homepage URL
Email kageyama862@eps.co.jp

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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective analysis of an existing internet-based questionnaire

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038998

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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