UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of respiratory mechanics in patients with obstructive lung diseases
Title of the study (Brief title)	Evaluation of respiratory mechanics in patients with obstructive lung diseases
Region	Japan

Condition
Condition	bronchial asthma asthma-COPD overlap COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze clinical features and airway structural changes in patients with obstructive lung diseases.
Basic objectives2	Others
Basic objectives -Others	intergroup trial
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	patient characteristics wall thickness of airway luminal area of airway pulmonary function tests broadband forced oscillation technique
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 were diagnosed with obstructive lung diseases. Patients who gave written informed consent.
Key exclusion criteria	Patients who could not underwent pulmonary function test, forced oscillation test or chest computed tomography. Patients who did not give written informed consent.
Target sample size	60

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu university school of medicine
Division name	The second division, department of internal medicine
Address	Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Mitsuru Niwa
Organization	Hamamatsu university school of medicine
Division name	The second division, department of internal medicine
Address	Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL	053-435-2263
Homepage URL
Email	mtr.nw@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)

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	2017 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 25 Day
Anticipated trial start date	2015 Year 04 Month 01 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	observational study

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033077