UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020803
Receipt No. R000024015
Scientific Title A method comparison study of FeNO measurements, between the NOA280i and the NIOX VERO
Date of disclosure of the study information 2016/02/01
Last modified on 2019/08/02 (Ver. 10)

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Basic information
Public title A method comparison study of FeNO measurements, between the NOA280i and the NIOX VERO
Acronym A method comparison study of FeNO measurements, between the NOA280i and the NIOX VERO
Scientific Title A method comparison study of FeNO measurements, between the NOA280i and the NIOX VERO
Scientific Title:Acronym A method comparison study of FeNO measurements, between the NOA280i and the NIOX VERO
Region
Japan

Condition
Condition asthma
Classification by specialty
Pneumology Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether FeNO values obtained with the NIOX VERO are comparable with the NOA280i.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Coefficient calculated for FeNO values obtained with the NOA280i and the NIOX VERO
Key secondary outcomes Bland-Altman plot used to assess agreement between FeNO values obtained with the NOA280i and the NIOX VERO

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 FeNO values are measured in all participants, using both the NIOX VERO and the NOA280i.
Three acceptable measurement is performed with each device.
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 Asthmatic patients who give written informed consent to this study.
Key exclusion criteria Those who need oxygenation.
Those who can not perform technically adequate measurements.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Taisuke
Middle name
Last name Akamatsu
Organization Shizuoka General Hospital
Division name Pneumology
Zip code 420-8527
Address 4-27-1 Kita-ando, Shizuoka city, Shizuoka, Japan
TEL 054-247-6111
Email taisuke-akamatsu@i.shizuoka-pho.jp

Public contact
Name of contact person
1st name Taisuke
Middle name
Last name Akamatsu
Organization Shizuoka General Hospital
Division name Pneumology
Zip code 420-8527
Address 4-27-1 Kita-ando, Shizuoka city, Shizuoka, Japan
TEL 054-247-6111
Homepage URL
Email taisuke-akamatsu@i.shizuoka-pho.jp

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization Shizuoka General Hospital
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 Clinical Research Ethics Committee, Shizuoka General Hospital
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
Tel 054-247-6111
Email chiken-sougou@shizuoka-pho.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 静岡県立総合病院

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 Day

Related information
URL releasing protocol https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S1081120617305938?returnurl=https:%2F%2Flin
Publication of results Published

Result
URL related to results and publications https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S1081120617305938?returnurl=https:%2F%2Flin
Number of participants that the trial has enrolled 107
Results 
FeNO levels measured using the NIOX VERO (mean +- SD 53.4 +- 38.9 ppb) were significantly higher than those using the NOA 280i (41.7 +- 33.2 ppb; P < .0001). However, there was a significant correlation between FeNO levels measured with the two devices (r = 0.946, P < .0001). The Bland-Altman plot showed a moderate degree of agreement between the 2 devices; the mean inter-device difference was 11.7 ppb (95% limits of agreement -13.5 and 37.0 ppb).
Results date posted
2019 Year 08 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Subjects included 107 adult patients with bronchial asthma (51 men and 56 women; 59 nonsmokers, 46 ex-smokers, and 2 current smokers; 75 with and 32 without atopy; mean age 60 years, mean body mass index 24.0 kg/m 2 , and mean predicted percentage of forced expiratory volume in 1 second 82.6%).
Participant flow 
There were no excluded patients.
Adverse events 
No troubles.
Outcome measures 
- Coefficient calculated for FeNO values obtained with the NOA280i and the NIOX VERO
- Bland-Altman plot used to assess agreement between FeNO values obtained with the NOA280i and the NIOX VERO
(See Results)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
2015 Year 12 Month 27 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 01 Month 31 Day
Date analysis concluded
2017 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 30 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024015