UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Title of the study (Brief title)	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	Hisamichi Aizawa
Organization	Kurume University School of Medicine
Division name	Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Address	67 Asahimachi, Kurume, Fukuoka, Japan
TEL	0942-31-7560
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person	Kazako Matsunaga
Organization	Kurume University School of Medicine
Division name	Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Address	67 Asahimachi, Kurume
TEL	0942-31-7560
Homepage URL
Email	kmatsunaga@med.kurume-u.ac.jp

Sponsor
Institute	Kyusyu Asthma & COPD Forum
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004126