UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024887 |
|---|---|
| Receipt number | R000028640 |
| Scientific Title | Comparison two fractional exhaled nitric oxide analyzers: NOA280i chemiluminescence analyzer and NIOXvero electrochemical analyzer |
| Date of disclosure of the study information | 2016/11/17 |
| Last modified on | 2017/02/28 12:36:27 |
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Basic information
Public title
Comparison two fractional exhaled nitric oxide analyzers: NOA280i chemiluminescence analyzer and NIOXvero electrochemical analyzer
Acronym
Comparison two fractional exhaled nitric oxide analyzers
Scientific Title
Comparison two fractional exhaled nitric oxide analyzers: NOA280i chemiluminescence analyzer and NIOXvero electrochemical analyzer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Norihiro Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5802-1063
nor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5802-1063
Homepage URL
nor@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028640
