UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the respiratory resistance in patients with chronic respiratory diseases: Comparison between Mostgraph and MasterScreen-IOS
Title of the study (Brief title)	Evaluation of the respiratory resistance: Comparison between Mostgraph and MasterScreen-IOS
Region	Japan

Condition
Condition	chronic respiratory diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate if the respiratory resistance derived from Mostgrph is comparable to that from MasterScreen-IOS in the patients with chronic respiratory diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Values of resspiratory rsistance including R5, R20, R5-20, X5, AX, and Fres derived from the patients with chronic respiratory diseases
Key secondary outcomes	Values of resspiratory rsistance including R5, R20, R5-20, X5, AX, and Fres derived from the healthy subjects

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Both MasterScreen-IOS and Mostgraph are performed in the same patient
Interventions/Control_2	Both MasterScreen-IOS and Mostgraph are performed in the same healthy subjects
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) COPD patients(GOLD I-III) 2) stable condition in term of respiratory symptoms, such as cough, sputum, and dyspnea
Key exclusion criteria	1) patients who receive home oxygen therapy or patients with chronic respiratory failure 2) patients who is considered to be inadequate for this study by their clinicians
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuhisa Takahashi
Organization	Juntendo University
Division name	Department of Respiratory Medicine
Address	2-1-1 Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan
TEL	+81-3-3813-3111
Email	kztakaha@juntendo.ac.jp

Public contact
Name of contact person	Mitsuaki Sekiya
Organization	Juntendo University
Division name	Department of Respiratory Medicine
Address	2-1-1 Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan
TEL	+81-3-3813-3111
Homepage URL
Email	msekiya@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Juntendo University, Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 16 Day
Anticipated trial start date	2012 Year 05 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 01 Day
Last modified on	2016 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009257