UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Title of the study (Brief title)	Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Region	Japan

Condition
Condition	CPOD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of inhaled budesonide/formoterol combination in COPD patients with eosinophilic airway inflammation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in FEV1 between week 0 and week 8.
Key secondary outcomes	Change in FVC between week 0 and week 8 Change in FEV1/FVC between week 0 and week 8 Change in FOT parameters between week 0 and week 8 Change in CAT between week 0 and week 8 Change in mMRC between week 0 and week 8 Change in FeNO between week 0 and week 8 Change in sputum eosinophils between week 0 and week 8

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	Additive administration of budesonide/formoterol
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) A Patient who is visiting our outpatient clinic, is over 40 years of age, and has smoking history 2) A patient who smoke 1 pack per day for 10 years or more 3) A patient who agreed to participate in the study with the written informed consent 4) A patients who have FeNO >35 ppb or sputum eosinophils >3%
Key exclusion criteria	1) A Patients with asthma. 2) A patients who have has experienced an acute COPD exacerbation or respiratory tract infection within the past 12 weeks prior to the informed consent 3) A patients receiving oxygen inhalation 4) A patient whom the doctor in charge judged unsuitable as subjected is excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
Address	4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL	054-247-6111
Email	taisuke-akamatsu@i.shizuoka-pho.jp

Public contact
Name of contact person	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
Address	4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL	054-247-6111
Homepage URL
Email	taisuke-akamatsu@i.shizuoka-pho.jp

Sponsor
Institute	Department of Respiratory Medicine, Shizuoka General Hospital
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)

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	2016 Year 07 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 26 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	2016 Year 07 Month 24 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026861