UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019965 |
|---|---|
| Receipt number | R000014605 |
| Scientific Title | Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics |
| Date of disclosure of the study information | 2015/11/28 |
| Last modified on | 2019/09/12 14:18:21 |
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Basic information
Public title
Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics
Acronym
Anti-inflammatory effect after SFC step down
Scientific Title
Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics
Scientific Title:Acronym
Anti-inflammatory effect after SFC step down
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the airway anti-inflammatory effect of salmeterol/fluticasone combination inhaler between continuation therapy with SFC250 and step down therapy with SFC100
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of FeNO value after 1 year treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To continue 1 year treatment with SFC250 or
Interventions/Control_2
To receive step down treatment with SFC100
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The asthmatics treated for at least 6 months with SFC 250 Diskus 2 puffs daily therapy, in whom the disease was well-controlled or totally controlled,i.e., an ACT score of 20-25 points, were eligible
Key exclusion criteria
Current smokers, those who had a smoking history (smoking index > 400) and patients with suspected COPD were excluded
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hojo |
Organization
National Center for Global Health and Medicine
Division name
Division of Respiratory Medicine
Zip code
1628655
Address
1-21-1Toyama, Shinjuku-ku, Tokyo, Japan 1628655
TEL
03-3202-7181
mhojo@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Hojo |
Organization
National Center for Global Health and Medicine
Division name
Division of Respiratory Medicine
Zip code
1628655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan 1628655
TEL
03-3202-7181
Homepage URL
mhojo@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1Toyama,Shinjuku-ku,Tokyo,Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
| 2015 | Year | 11 | Month | 28 | 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
25
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
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
