UMIN-CTR Clinical Trial

Basic information
Public title	Prospective combined analysis of spirometry, impulse oscillation, and chest tomography for the effect of salmeterol/fluticasone (SFC) in COPD
Acronym	Prospective analysis of spirometry and chest tomography for the effect of salmeterol/fluticazone (SFC) in COPD
Scientific Title	Prospective combined analysis of spirometry, impulse oscillation, and chest tomography for the effect of salmeterol/fluticasone (SFC) in COPD
Scientific Title:Acronym	Prospective analysis of spirometry and chest tomography for the effect of salmeterol/fluticazone (SFC) in COPD
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the new indicators for the effect on lung hyperinflation with treatment of SFC in COPD, using combined analysis of spirometry, oscillation, and chest tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	inspiratory capacity
Key secondary outcomes	1) subjective dyspnea 2)spirometry 3)R5, R20, R5-R20, and X5 on oscillation 4)Total lung capacity and emphysema lung volume on inspiratory phase expiratory phase by chest tomograpghy 5) subanalysis of lung hyperinflation and subjective dyspnea in both responder and non-responder for SFC

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	SFC250 1 inhaler per time, twice a day
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. FEV1.0/FVC70%below after bronchodilator 2. not receiving any treatment of inhaled steroid, long-term b stimulant, and/or anti-cholinergic agent
Key exclusion criteria	1. any disease with possible air flow limitation defined as below 2.defined as below; bronchial asthma, diffuse pan bronchitis, sinobronchial syndrome, bronchial ectasis, tuberculosis, pneumoconiosis, lymphangioleiomyomatosis, congestic heart failure, and interstitial pneumonia detected by chest Xray 3. contraindication to SFC treatment
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Hasegawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	0527442167
Email	yhasega@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Naozumi Middle name Last name Hashimoto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	0527442167
Homepage URL
Email	hashinao@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board
Address	65 Tsurumai Showa-ku Nagoya
Tel	0527412111
Email	hashinao@med.nagoya-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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 25 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	Immature result
Number of participants that the trial has enrolled	34
Results	The clinical trial was discontinued due to small numbers.
Results date posted	2020 Year 09 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	COPD
Participant flow	written informed consent
Adverse events	none
Outcome measures	The studu did not have any conclusion.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 08 Month 17 Day
Date of IRB	2011 Year 06 Month 13 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2012 Year 09 Month 06 Day
Date of closure to data entry	2012 Year 10 Month 31 Day
Date trial data considered complete	2012 Year 10 Month 31 Day
Date analysis concluded	2013 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date	2010 Year 08 Month 25 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004931