UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020605 |
|---|---|
| Receipt number | R000023783 |
| Scientific Title | Forced oscillation technique as a predictor of improvement in FEV1 in asthma |
| Date of disclosure of the study information | 2016/01/17 |
| Last modified on | 2017/07/19 13:19:25 |
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Basic information
Public title
Forced oscillation technique as a predictor of improvement in FEV1 in asthma
Acronym
Forced oscillation technique as a predictor of improvement in FEV1 in asthma
Scientific Title
Forced oscillation technique as a predictor of improvement in FEV1 in asthma
Scientific Title:Acronym
Forced oscillation technique as a predictor of improvement in FEV1 in asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether forced oscillation technique (FOT) could predict improvement in FEV1 after treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between FOT parameters at baseline and the ratio of improvement in FEV1
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
Patients who had performed FOT, pulmonary function tests and FeNO measurement before and after ICS/LABA treatment at more than 2-month intervals.
Key exclusion criteria
Patients were excluded from the study if they were current smokers, had a smoking history of > 10 pack-years, or had quit smoking within 1 year prior to the study and had COPD.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
Organization
Shizuoka General Hospital
Division name
respiratory medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka
TEL
054-247-6111
taisuke-akamatsu@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
Organization
Shizuoka General Hospital
Division name
respiratory medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka
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
none
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 | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively collected clinical data of outpatients who had performed FOT, pulmonary function tests, and FeNO measurement before and after ICS/LABA treatment at more than 2-month intervals at Shizuoka General Hospital between July 2010 and June 2014.
Management information
Registered date
| 2016 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023783
