UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010333 |
|---|---|
| Receipt number | R000012095 |
| Scientific Title | Study of step-down therapy from formoterol/budesonide combinations in patients with asthma |
| Date of disclosure of the study information | 2013/03/27 |
| Last modified on | 2013/09/27 20:18:52 |
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Basic information
Public title
Study of step-down therapy from formoterol/budesonide combinations in patients with asthma
Acronym
Step-down therapy from formoterol/budesonide combinations
Scientific Title
Study of step-down therapy from formoterol/budesonide combinations in patients with asthma
Scientific Title:Acronym
Step-down therapy from formoterol/budesonide combinations
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of the step-down therapy in patients with bronchial asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Asthma attack during the treatment period
Key secondary outcomes
Lung function during the treatment period
QOL score during the treatment period
FeNO during the treatment period
Adverse events during the treatment period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to one inhalation twice daily for 12 weeks
Interventions/Control_2
Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to budesonide (Pulmicort) 200ug two inhalation twice daily for 12 weeks
Interventions/Control_3
Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to mometasone(asmanex) 200ug one inhalation twice daily for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ability and willingness to provide informed consent
Budesonide/formoterol (Symbicort) 160/4.5ug two inhalation twice daily at constant dose for 2 months
Achieve good control of the GINA criteria
Key exclusion criteria
History of presence of lung, cardiac, renal and liver disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Hashimoto |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL
053-435-2263
Homepage URL
dai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012095
| 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 |
