UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025689
Receipt No. 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 (Ver. 7)

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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
Email 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
Email taisuke-akamatsu@i.shizuoka-pho.jp

Sponsor
Institute Department of Respiratory Medicine, Shizuoka General Hospital
Institute
Department

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
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（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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029554