UMIN-CTR Clinical Trial

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
Last 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
Email	ikkou@m2.kufm.kagoshima-u.ac.jp

Public contact
1st 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
Email	machida@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima university pulmonary medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010664