UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010711 |
|---|---|
| Receipt number | 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 14:33:12 |
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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
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
Sponsor or person
Institute
Third Department of Internal Medicine, Wakayama Medical University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012518
