UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009519 |
|---|---|
| Receipt number | R000010712 |
| Scientific Title | Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(Salbutamol) about bronchodilating effect part and onset of relief of dyspnea. |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2020/06/26 15:00:04 |
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Basic information
Public title
Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(Salbutamol) about bronchodilating effect part and onset of relief of dyspnea.
Acronym
Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(salbutamol)about bronchodilating effect part and onset of relief of dyspnea.
Scientific Title
Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(Salbutamol) about bronchodilating effect part and onset of relief of dyspnea.
Scientific Title:Acronym
Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(salbutamol)about bronchodilating effect part and onset of relief of dyspnea.
Region
| Japan |
Condition
Condition
Adults who were induced bronchoconstriction by methacholine.
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare bronchodilating effect among FM/BUD, SM/FP, SB.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory impedance, Borg scale
Key secondary outcomes
FEV1.0, Lung capacity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Formoterol/Budesonide
Interventions/Control_2
Salmeterol/Fluticasone
Interventions/Control_3
Salbutamol
Interventions/Control_4
Control(No treatment)
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female aged between 20 and 40 years.
2.The forced expiratory volume in one second has to at least 70 percent of predicted value.
Key exclusion criteria
1.Aortic aneurysm
2.Pregnancy
3.History of cerebral infarction within three months.
4.Breast-feeding women
5.Hypertension
6.Diabetes mellitus
7.Hyperthyroidism
8.Cardiac disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Atsuta |
Organization
Juntendo University
Division name
Respiratory Medicine
Zip code
1138421
Address
3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0358021063
atsuta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yukinari |
| Middle name | |
| Last name | Itoigawa |
Organization
1978
Division name
Respiratory Medicine
Zip code
3300062
Address
3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1063
Homepage URL
yuitoiga@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
11
Results
N/A
Results date posted
| 2020 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010712
| 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 |
