UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011853 |
|---|---|
| Receipt number | R000013856 |
| Scientific Title | Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics. |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2013/09/24 21:23:55 |
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Basic information
Public title
Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.
Acronym
anti-inflammatory effect of BUD/FM inhaler
Scientific Title
Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.
Scientific Title:Acronym
anti-inflammatory effect of BUD/FM inhaler
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the long-term airway anti-inflammatory effect of fix-dosed maintenance therapy with budesonide/formoterol combination inhaler with other treatment including ICS alone or salmeterol/fluticasone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FeNO, as a marker of airway inflammation
Key secondary outcomes
asthma control test (ACT) score, and the number of SABA use
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Budesonide/formoterol(BUD/FM)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The asthmatics treated for at least 6 months with SFC250 2 puffs/day or BUD 800 micro-g + SLM 100 micro-g /day treatment in whom well-controlled status were maintained
Key exclusion criteria
Current smokers, those who had a smoking history (smoking index > 400) and patients with suspected COPD were excluded
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hojo |
Organization
National Center for Global Health and Medicine
Division name
Devision of Respiratory Medicine
Zip code
Address
Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL
03-3202-7181
mhojo@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Hojo |
Organization
National Center for Global Health and Medicine
Division name
Devision of Respiratory Medicine
Zip code
Address
Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
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
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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 15 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2013 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013856
