UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Forced oscillation technique as a predictor of improvement in FEV1 in asthma
Title of the study (Brief title)	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	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	respiratory medicine
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	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	respiratory medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023783