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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010711
Receipt No. R000012518
Scientific Title Investigation of biomarkers for predicting the response to steroids in patients with COPD
Date of disclosure of the study information 2013/06/01
Last modified on 2016/10/02

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Basic information
Public title Investigation of biomarkers for predicting the response to steroids in patients with COPD
Acronym Steroid responsiveness in COPD
Scientific Title Investigation of biomarkers for predicting the response to steroids in patients with COPD
Scientific Title:Acronym Steroid responsiveness in COPD
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the biomarkers for predicting the response to steroids in COPD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Steroid response in lung function
Key secondary outcomes Steroid response in QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Corticosteroids
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1, COPD based on diagnosis criteria
2, non-smoker
3, non-steroid user
4, no systemic inflammatory disease
5, non-LTOT user
6, agreement to participant the study
Key exclusion criteria 1, Smoking, exacerbation, infection during the study period
2, Poor adherence
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Matsunaga
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address Kimiidera811-1, Wakayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuto Matsunaga
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address Kimiidera 811-1, Wakayama
TEL
Homepage URL
Email

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)

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
2013 Year 06 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
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
2013 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 14 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=R000012518

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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