UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a symptom-based COPD population screenier (COPD-PS) questionnaire for COPD patients
Title of the study (Brief title)	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	Seiichi Kobayashi
Organization	Japanese Red Cross Ishinomaki Hospital
Division name	Department of Respiratory Medicine
Address	71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL	0225-21-7220
Email	skoba-thk@umin.ac.jp

Public contact
Name of contact person	Seiichi Kobayashi
Organization	Japanese Red Cross Ishinomaki Hospital
Division name	Department of Respiratory Medicine
Address	71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL	0225-21-7220
Homepage URL
Email	skoba-thk@umin.ac.jp

Sponsor
Institute	Ishinomaki COPD Network
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013384