UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014191 |
|---|---|
| Receipt number | R000016526 |
| Scientific Title | Effect of RELVAR on asthma COPD overlap syndrome |
| Date of disclosure of the study information | 2014/06/14 |
| Last modified on | 2014/12/10 17:57:51 |
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Basic information
Public title
Effect of RELVAR on asthma COPD overlap syndrome
Acronym
Effect of RELVAR on ACOS
Scientific Title
Effect of RELVAR on asthma COPD overlap syndrome
Scientific Title:Acronym
Effect of RELVAR on ACOS
Region
| Japan |
Condition
Condition
Asthma COPD overlap syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the clinical effect of Relvar for asthma COPD overlap syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Symptoms evaluated bu QOL quastionare
Key secondary outcomes
Respiratory function tests
Base
Study type
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment by Relvar
Interventions/Control_2
Treatment by Adoair
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
asthma COPD overlap syndrome
Key exclusion criteria
without active infection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumihokubumachi, Toyama City, Toyama Japan
TEL
+81-76-422-1112
ishiura@tch.toyama.toyama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumihokubumachi, Toyama City, Toyama Japan
TEL
+81-76-422-1112
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Respiratory Medicine, Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Medicine, Toyama City Hospital
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
富山市民病院呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2014 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
