UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010825 |
|---|---|
| Receipt number | R000012678 |
| Scientific Title | Study of evaluation for efficacy and safety of SMART(Symbicort Maintenance and Reliever Therapy) in poorly controlled asthmatics |
| Date of disclosure of the study information | 2013/05/29 |
| Last modified on | 2020/12/03 14:48:16 |
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Basic information
Public title
Study of evaluation for efficacy and safety of SMART(Symbicort Maintenance and Reliever Therapy) in poorly controlled asthmatics
Acronym
SMART(Symbicort Maintenance and Reliever Therapy) in poorly controlled asthmatics
Scientific Title
Study of evaluation for efficacy and safety of SMART(Symbicort Maintenance and Reliever Therapy) in poorly controlled asthmatics
Scientific Title:Acronym
SMART(Symbicort Maintenance and Reliever Therapy) in poorly controlled asthmatics
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of SMART (Symbicort Maintenance and Reliever Therapy)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ACT score
Key secondary outcomes
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
SMART(Symbicort Maintenance and Reliever Therapy)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
poorly controlled asthmatics (ACT score<=24)
Key exclusion criteria
contraindications of Symbicort
current smoker
Infections within 2 weeks
Systemic steroid administration within 2 weeks
Pregnant patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Hirata |
Organization
Graduate school of medicine, Osaka City University
Division name
Department of Respiratory medicine
Zip code
545-8585
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3916
kokyuki@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Asai |
Organization
Graduate school of medicine, Osaka City University
Division name
Department of Respiratory medicine
Zip code
545-8585
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3916
Homepage URL
kokyuki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Respiratory medicine, Graduate school of medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory medicine, Graduate school of medicine, Osaka City University
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
ethics commitee, Osaka City University
Address
1-4-3, asahimachi, Abeno, Osaka JAPAN
Tel
06-6645-3435
rinri@med.osaka-cu.ac.jp
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 | 05 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 29 | Day |
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 | 29 | Day |
Last modified on
| 2020 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012678
| 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 |
