UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of forced oscillation technique for interstitial lung diseases
Acronym	Investigation of FOT for ILD
Scientific Title	Investigation of forced oscillation technique for interstitial lung diseases
Scientific Title:Acronym	Investigation of FOT for ILD
Region	Japan

Condition
Condition	Interstitial lung diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate utility of the forced oscillation technique (FOT) for evaluation of clinical course, prognosis and pathophysiology in interstitial lung disease such as idiopathic pulmonary fibrosis.
Basic objectives2	Others
Basic objectives -Others	Efficacy of FOT in ILD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation with parameters of the forced oscillation technique (FOT) and clinical course, prognosis and pulmonary function tests.
Key secondary outcomes	Correlation between parameters of the forced oscillation technique (FOT) and findings of high-resolution computed tomography (HRCT).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	measurement of impedance by forced oscillation technique (FOT) Taking high resolution computed tomography (HRCT) pulmonary function test
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients diagnosed as having interstitial lung diseases such as idiopathic interstitial pneumonia
Key exclusion criteria	Patients who are difficult to measure the FOT or pulmonary function tests Patients who are unable to get informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code
Address	1-20-1 Handayama Higashi-ku, Hamamatsu
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoyuki Fujisawa
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code
Address	1-20-1 Handayama Higashi-ku, Hamamatsu
TEL	053-435-2263
Homepage URL
Email	fujisawa@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
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 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2013 Year 12 Month 06 Day
Date of IRB	2013 Year 12 Month 16 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 25 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023890