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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020605
Receipt No. 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

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

Sponsor
Institute Shizuoka General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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