UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013490 |
|---|---|
| Receipt number | 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 15:33:52 |
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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
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
sayomimatsu@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University Schoo of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015755
