UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025689 |
|---|---|
| Receipt number | R000029554 |
| Scientific Title | Relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide in adult asthma |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2020/07/21 14:22:49 |
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Basic information
Public title
Relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide in adult asthma
Acronym
Relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide
Scientific Title
Relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide in adult asthma
Scientific Title:Acronym
Relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify relationship between forced oscillation technique and asthma control or fractional exhaled nitric oxide
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in forced oscillation technique between patients with and without controlled asthma
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
Patient with asthma
Key exclusion criteria
case which family doctor judged to be unsuitable as experimental object
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Shirai |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
4208527
Address
4-27-1 Kita-ando, Aoi, Shizuoka
TEL
054-247-6111
toshihiro-shirai@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Akamatsu |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
4208527
Address
4-27-1 Kita-ando, Aoi, Shizuoka
TEL
054-247-6111
Homepage URL
taisuke-akamatsu@i.shizuoka-pho.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shizuoka General Hospital Research Support Office
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（静岡県）、平松内科（愛知県）、古井医院（岐阜県）、はなさきクリニック（愛知県）、近畿大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/all.14484
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1111/all.14484
Number of participants that the trial has enrolled
143
Results
Oscillometric parameters, including R5, R5-R20, X5, Fres, and AX, but not FEV1, significantly worsened after a 3-month period of observation in the high FeNO group but not in the low FeNO group. FeNO decreased significantly in the high FeNO group but not in the low FeNO group. There were correlations between baseline FeNO levels and changes in R5 and R5-R20 in the high FeNO group. Multiple logistic regression analysis revealed that R5 and R5-R20 were associated with higher FeNO levels.
Results date posted
| 2020 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 97 subjects who completed the study, 28 (28.9%) patients had FeNO levels > 35 ppb. There was no difference in the demographic, ACT, and lung function data between high and low FeNO groups at baseline except for FeNO levels
Participant flow
One hundred and forty-three patients were screened and 46 patients were excluded upon entry because of asthma exacerbation, a change in medications, or difficulty in taking measurements.
Adverse events
none
Outcome measures
The patients were classified into high or low FeNO groups (FeNO > 35 ppb or < 35 ppb) based on the baseline FeNO levels. The primary outcomes were the changes in oscillometric parameters.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Continue or change the treatment baed on asthma control at baseline (week0).
Evaluate asthma control after 4-12 weeks.
Management information
Registered date
| 2017 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029554
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
