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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010825
Receipt No. 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

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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
Email 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
Email kokyuki@med.osaka-cu.ac.jp

Sponsor
Institute Department of Respiratory medicine, Graduate school of medicine, Osaka City University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012678

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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