UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003403 |
|---|---|
| Receipt number | R000004126 |
| Scientific Title | Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2017/10/03 18:16:55 |
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Basic information
Public title
Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Acronym
Additional effects of SFC in patients with COPD
Scientific Title
Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Scientific Title:Acronym
Additional effects of SFC in patients with COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that moderate-dose (500mcg/day) fluticasone and salmeterol combination therapy prevents exacerbation and airflow limitation in Japanese patients with COPD, a randomized, parallel-group, open label trial is conducted.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevent the numbers and severity of exacerbation/yr/patient
Key secondary outcomes
Prevent the decline of FEV1
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add on treatment with inhaled 250mcg dose of SFC (twice daily), everyday, for 3years
Interventions/Control_2
control
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
COPD
Key exclusion criteria
1. other respiratory diseases
2. regular use of inhaled corticosteroids
3. regular use of inhaled and transdermal beta2 agonists
4. severe other orgen diseases
5. active malignancies
Target sample size
1008
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisamichi Aizawa |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address
67 Asahimachi, Kurume, Fukuoka, Japan
TEL
0942-31-7560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazako Matsunaga |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address
67 Asahimachi, Kurume
TEL
0942-31-7560
Homepage URL
kmatsunaga@med.kurume-u.ac.jp
Sponsor or person
Institute
Kyusyu Asthma & COPD Forum
Institute
Department
Personal name
Funding Source
Organization
KASCOM
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
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
| 2010 | Year | 04 | Month | 01 | 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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004126
