UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison two fractional exhaled nitric oxide analyzers: NOA280i chemiluminescence analyzer and NIOXvero electrochemical analyzer
Title of the study (Brief title)	Comparison two fractional exhaled nitric oxide analyzers
Region	Japan

Condition
Condition	Bronchial asthma Chronic cough
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine whether there is a difference between a stationary electrochemical analyzer NOA280i (Sievers Instruments, Boulder, CO, USA) and the hand-held electrochemical analyzer NIOXvero (Aerocrine, Solna, Sweden).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison two fractional exhaled nitric oxide analyzers: NOA280i chemiluminescence analyzer and NIOXvero electrochemical analyzer
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject is diagnosed or suspected with asthma.
Key exclusion criteria	Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.
Target sample size	3500

Research contact person
Name of lead principal investigator	Norihiro Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Email	nor@juntendo.ac.jp

Public contact
Name of contact person	Norihiro Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Homepage URL
Email	nor@juntendo.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
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 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 05 Month 20 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	The method of recruitment; Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital by March 31, 2017.

Management information
Registered date	2016 Year 11 Month 17 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028640