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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013490
Receipt No. R000015755
Scientific Title A survey of patients of chronic obstructive pulmonary disease (COPD) in Shizuoka prefecture
Date of disclosure of the study information 2014/04/01
Last modified on 2018/03/26

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Basic information
Public title A survey of patients of chronic obstructive pulmonary disease (COPD) in Shizuoka prefecture
Acronym A survey of COPD patients
Scientific Title A survey of patients of chronic obstructive pulmonary disease (COPD) in Shizuoka prefecture
Scientific Title:Acronym 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
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Sayomi Matsushima
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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)
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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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