UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011434
Receipt number R000013384
Scientific Title Evaluation of a symptom-based COPD population screenier (COPD-PS) questionnaire for COPD patients
Date of disclosure of the study information 2013/08/08
Last modified on 2017/11/01 00:03:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of a symptom-based COPD population screenier (COPD-PS) questionnaire for COPD patients

Acronym

COPD-PS in diagnosed COPD

Scientific Title

Evaluation of a symptom-based COPD population screenier (COPD-PS) questionnaire for COPD patients

Scientific Title:Acronym

COPD-PS in diagnosed COPD

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Usefullness of a symptom-based COPD population screenser (COPD-PS) questionnaire in diagnosed COPD patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

sensitivity of COPD by COPD-PS

Key secondary outcomes

Influence of respiratory symptom, pulmonary function, and comorbidities with COPD-PS score


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

diagnosed COPD

Key exclusion criteria

patients without spirometric results

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiichi Kobayashi

Organization

Japanese Red Cross Ishinomaki Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

71 Nishimichishita, Hebita, Ishinomaki, Japan

TEL

0225-21-7220

Email

skoba-thk@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiichi Kobayashi

Organization

Japanese Red Cross Ishinomaki Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

71 Nishimichishita, Hebita, Ishinomaki, Japan

TEL

0225-21-7220

Homepage URL


Email

skoba-thk@umin.ac.jp


Sponsor or person

Institute

Ishinomaki COPD Network

Institute

Department

Personal name



Funding Source

Organization

Ishinomaki COPD Network

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

石巻赤十字病院


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2013 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 12 Day

Last follow-up date

2016 Year 03 Month 30 Day

Date of closure to data entry

2016 Year 03 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2013 Year 08 Month 08 Day

Last modified on

2017 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013384


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name