UMIN-CTR Clinical Trial

Basic information
Public title	To establish the roll of reactive sulfur species in COPD lung
Acronym	Reactive sulfur species in COPD lung
Scientific Title	To establish the roll of reactive sulfur species in COPD lung
Scientific Title:Acronym	Reactive sulfur species in COPD lung
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the roll of reactive sulfur species in antioxidant system of human lung and develop new antioxidant therapy for COPD.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To elucidate the mechanism of reactive sulfur species in human normal lung and COPD lung.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	COPD patients diagnosed by spirometry and healthy volunteers
Key exclusion criteria	patients and healthy volunteers who deny participating in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Ichikawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	980-8574
Address	1-1 Seiryoumachi, Aobaku, Sendai
TEL	022-717-8539
Email	ichikawa@rm.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Ichikawa
Organization	Tohoku University Graduate School of
Division name	Department of Respiratory Medicine
Zip code	980-8574
Address	1-1 Seiryoumachi, Aobaku, Sendai
TEL	022-717-8539
Homepage URL
Email	ichikawa@rm.med.tohoku.ac.jp

Sponsor
Institute	Department of Respiratory Medicine,Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Medicine
Address	2-1 Seiryoumachi,Aobaku,Sendai Japan
Tel	022-717-8007
Email	med-kenkyo@bureau.tohoku.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	東北大学大学院医学系研究科（宮城県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 10 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	2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2014 Year 04 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	Human lung tissues

Management information
Registered date	2015 Year 03 Month 06 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019256