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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008102
Receipt No. 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

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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
Email 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
Email obaseya@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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