UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020803 |
|---|---|
| Receipt number | 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 18:49:51 |
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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
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
taisuke-akamatsu@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024015
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