UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A survey of patients of chronic obstructive pulmonary disease (COPD) in Shizuoka prefecture
Title of the study (Brief title)	A survey of COPD patients
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease (COPD)
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the factor exerted on the natural course of COPD.
Basic objectives2	Others
Basic objectives -Others	To research effects and adverse events of drugs.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pulmonary function test (PFT)
Key secondary outcomes	The kind and frequency of adverse events

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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of chronic obstructive pulmonary disease (FEV1/ FVC< 0.7)
Key exclusion criteria	Patients with bronchial asthma Judgement of attending physician
Target sample size	400

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi, Hamamatsu, Shizuoka, 433-8122, Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Sayomi Matsushima
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi, Hamamatsu
TEL	053-435-2263
Homepage URL
Email	sayomimatsu@yahoo.co.jp

Sponsor
Institute	Hamamatsu University Schoo of Medicine
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	2014 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 28 Day
Date trial data considered complete	2018 Year 02 Month 28 Day
Date analysis concluded	2018 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The beneficial effects of inhaled corticosteroids might be obtained at lower doses in patients with COPD. Clinical Medicine Insights: Circulatory, Pulmonary and Respiratory Medicine (in press)
Other related information	Retrospective study

Management information
Registered date	2014 Year 03 Month 23 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015755