UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008102 |
|---|---|
| Receipt number | R000009533 |
| Scientific Title | The efficacy of salmeterol/fluticasone inhalation on systemic inflammatory markers in patients with chronic obstructive pulmonary diseases |
| Date of disclosure of the study information | 2012/06/05 |
| Last modified on | 2015/06/05 12:42:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of salmeterol/fluticasone inhalation on systemic inflammatory markers in patients with chronic obstructive pulmonary diseases
Acronym
SFC effects on the systemic inflammatory markers in COPD patients
Scientific Title
The efficacy of salmeterol/fluticasone inhalation on systemic inflammatory markers in patients with chronic obstructive pulmonary diseases
Scientific Title:Acronym
SFC effects on the systemic inflammatory markers in COPD patients
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of salmeterol/fluticasone inhalation on systemic inflammatory markers in patients with chronic obstructive pulmonary diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes of PARK/CCL-18, CC-16, serum arginase, and urinary beta isoprostane
Key secondary outcomes
The changes of lung function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
salmeterol inhalation
Interventions/Control_2
salmeterol/fluticasone inhalation
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
able to read and sign the letter of consent
be diagnosed as COPD
has FEV1/FVC <70%
has no other disease cause of the obstruction except COPD
with smoking status more than 10 pack years
able to inhale the discus inhalation medicine
able to fill in the CAT(COPD assessment test)
Key exclusion criteria
have any of tuberculosis or acute airway infections
associated with bronchial asthma
had COPD exacerbation in 4 weeks
with pregnacy, lactating
with any of severe heart disease, liver disease, renal disease, hematological disease or infection disease
who the doctor in charge judge as to be excepted
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Obase |
Organization
Kawasaki Medical School
Division name
Respiratory diseases
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
obaseya@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Obase |
Organization
Kawasaki Medical School
Division name
Respiratory diseases
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp/med/study/info.php?id=406
obaseya@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 05 | 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
| 2012 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009533
