UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034210
Receipt number 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 2020/10/28 12:23:57

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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 or person

Institute

AstraZeneca K.K.

Institute

Department

Personal name



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

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038998

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0289-5803/37060/77

Number of participants that the trial has enrolled

456

Results

The most frequent symptom was short breath/feeling of dyspnea at daytime (114 patients, 45%), and it occurred the any time of the day. There were 101 patients with impairment due to symptoms at any time of a day, the most common symptom is short breath/feeling of dyspnea at daytime. Of the 250 patients with COPD-related symptom, 114 patients (58%) were treated with some medication. patients who had proposal of therapeutic target were more likely to receive medication.

Results date posted

2020 Year 10 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Male 313(96.9%), Female 10(3.1%)

Participant flow

not applicable

Adverse events

not applicable

Outcome measures

Of the 323 patients with a history of emphysema or COPD, 250 patients (77%) were aware of some kinds of symptom.
In comparison by each time zone, the most frequent symptom was short breath/feeling of dyspnea at daytime (114 patients, 45%), and it occurred the any time of the day, including evening to bedtime.
There were 101 patients (40% of patients who were aware of symptom) with impairment due to symptoms at any time of a day, the most common symptom is short breath/feeling of dyspnea at daytime (72 patients,50%), in comparison with other times within a day.
Of the 250 patients with COPD-related symptom, 114 patients (58%) were treated with some medication. patients who had proposal of therapeutic target were more likely to receive medication.
In conclusion, the task is that the diffusion of appropriate COPD treatment in consideration of the type of symptom and the occurrence time of symptom and impairment. Appropriate communication between doctors and patients such as proposing therapeutic target at the beginning of treatment was considered important.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 09 Month 07 Day

Date of IRB

2018 Year 09 Month 20 Day

Anticipated trial start date

2018 Year 09 Month 20 Day

Last follow-up date

2018 Year 09 Month 20 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 11 Month 07 Day

Date analysis concluded

2019 Year 03 Month 06 Day


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

2020 Year 10 Month 28 Day



Link to view the page

Value
https://center6.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