UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of biomarkers for predicting the response to steroids in patients with COPD
Title of the study (Brief title)	Steroid responsiveness in COPD
Region	Japan

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

Objectives
Narrative objectives1	To investigate the biomarkers for predicting the response to steroids in COPD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Steroid response in lung function
Key secondary outcomes	Steroid response in QOL

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	Corticosteroids
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1, COPD based on diagnosis criteria 2, non-smoker 3, non-steroid user 4, no systemic inflammatory disease 5, non-LTOT user 6, agreement to participant the study
Key exclusion criteria	1, Smoking, exacerbation, infection during the study period 2, Poor adherence
Target sample size	80

Research contact person
Name of lead principal investigator	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	Kimiidera811-1, Wakayama
TEL
Email

Public contact
Name of contact person	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	Kimiidera 811-1, Wakayama
TEL
Homepage URL
Email

Sponsor
Institute	Third Department of Internal Medicine, Wakayama Medical University
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	2013 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 14 Day
Anticipated trial start date	2013 Year 06 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 14 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012518