UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	COPD Assessment in Practice
Title of the study (Brief title)	CAP study
Region	Japan

Condition
Condition	COPD
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop a useful practical assessment tool for patients with COPD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prediction of the severity of aiflow obstruction
Key secondary outcomes	Prediction of the risks of exacerbations

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	25 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with COPD
Key exclusion criteria	Exccerbation within a month Poor adherenece to the traetment
Target sample size	1400

Research contact person
Name of lead principal investigator	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third departmant of internal Medicine
Address	Kimiidera811-1, Wakayama
TEL	073-441-0619
Email	kazmatsu@wakayama-med.ac.jp

Public contact
Name of contact person	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	Kimiidera811-1, Wakayama
TEL	073-441-0619
Homepage URL
Email	kazmatsu@wakayama-med.ac.jp

Sponsor
Institute	Third department of Internal Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 10 Day
Anticipated trial start date	2013 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Cross-sectional observation of lung function, breathlessness, treatment, exacerbations

Management information
Registered date	2013 Year 12 Month 16 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014729