UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010276 |
|---|---|
| Receipt number | R000010664 |
| Scientific Title | The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction. |
| Date of disclosure of the study information | 2013/03/19 |
| Last modified on | 2019/03/24 22:40:51 |
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Basic information
Public title
The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction.
Acronym
Evaluation of Salmeterol/ Fluticasone propionate compound effecacy in chronic obstructive pulmonary disease.
Scientific Title
The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction.
Scientific Title:Acronym
Evaluation of Salmeterol/ Fluticasone propionate compound effecacy in chronic obstructive pulmonary disease.
Region
| Japan |
Condition
Condition
obstructive pulmonary dysfunction
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the predictive factors for the effect of salmeterol / fluticasone combination agent on patients with obstructive pulmonary dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FEV1
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
salmeterol/fulticasone propionate combination
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) FEV1/FVC< 70% pre-bronchodilator
2) Age 40-75 y.o.
3) possible observe for 4wks
4) consent in writing
Key exclusion criteria
1) medication of corticosteroid in 4wks
2) medication of anticholinergic drug in 4wks
3) medication of long acting beta agonist in 4 wks
4) inhalation of short acting beta agonist in 6hrs
5) patients who has heart failure, severe arrhythmia.
6) medication of beta blocker
7) active infectious disease and tuberculous disease
8) pationts who had resected lung
9) psycosomatic patients
10) allergy for SFC
11) difficult to do spirometry
12) pregnancy
13) diagnosis for other pulmonary disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | INOUE |
Organization
Kagoshima university
Division name
Pulmonary medicine
Zip code
8908570
Address
8-35-1Sakuragaoka Kagoshima city, Japan
TEL
099-275-6481
ikkou@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | MACHIDA |
Organization
Kagoshima university
Division name
pulmonary medicine
Zip code
8908570
Address
8-35-1Sakuragaoka Kagoshima city, Japan
TEL
0992756481
Homepage URL
machida@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima university pulmonary medicine
Institute
Department
Personal name
Funding Source
Organization
kagoshima university pulmonary medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kurume university
Tokai university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima university
Address
sakuragaoka 8-35-1, Kagoshima City
Tel
0992756481
machida@m.kufm.kagoshima-u.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
鹿児島大学病院（鹿児島県） Kagoshima university hospital
久留米大学病院（福岡県） Kurume university hosipital
東海大学病院（神奈川県） Tokai university hosipital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
| 2013 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010664
