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

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 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


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

Value
https://center6.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