UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005063 |
|---|---|
| Receipt number | R000005865 |
| Scientific Title | Study of step down from high dose of salmeterol/fluticasone propionate combination(SFC) with tiotropium to middle dose of SFC + ciclesonide(CIC) with tiotropium in well controlled asthmatic patients with COPD |
| Date of disclosure of the study information | 2011/02/10 |
| Last modified on | 2015/02/11 10:51:02 |
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Basic information
Public title
Study of step down from high dose of salmeterol/fluticasone propionate combination(SFC) with tiotropium to middle dose of SFC + ciclesonide(CIC) with tiotropium in well controlled asthmatic patients with COPD
Acronym
Study of step down from high dose SFC with tiotropium to middle dose SFC + CIC with tiotropium in well controlled asthmatic patients with COPD
Scientific Title
Study of step down from high dose of salmeterol/fluticasone propionate combination(SFC) with tiotropium to middle dose of SFC + ciclesonide(CIC) with tiotropium in well controlled asthmatic patients with COPD
Scientific Title:Acronym
Study of step down from high dose SFC with tiotropium to middle dose SFC + CIC with tiotropium in well controlled asthmatic patients with COPD
Region
| Japan |
Condition
Condition
Asthmatic patients with COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to evaluate the efficacy and safety of step down from high dose of salmeterol/fluticasone propionate combination(SFC) with tiotropium to middle dose of SFC + ciclesonide(CIC) with tiotropium in well controlled asthmatic patients with COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ACT score at three month and six month
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
ciclesonide
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)total or well controlled asthmatic patients with COPD treated with SFC(500ug/day) + tiotropium
2)ex-smoker
3)FEV1% < 70%
4)asthma control test score >= 20
5)no medication change for 12weeks
Key exclusion criteria
1)asthma control test score < 20
2)infection with bacteria or fungus
3)pregnancy
4)current smoker
5)investigator decision
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Hirata |
Organization
Graduate school of Medicine, Osaka City
University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3 asahimachi, abenoku, Osaka, Japan
TEL
06-6645-3916
kokyuki@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Asai |
Organization
Graduate school of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3916
Homepage URL
kokyuki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate school of Medicine, Osaka City University
Institute
Department
Personal name
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 10 | 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
| 2011 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2015 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005865
