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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007876
Receipt No. R000009257
Scientific Title Evaluation of the respiratory resistance in patients with chronic respiratory diseases: Comparison between Mostgraph and MasterScreen-IOS
Date of disclosure of the study information 2012/05/01
Last modified on 2016/07/15

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Basic information
Public title Evaluation of the respiratory resistance in patients with chronic respiratory diseases: Comparison between Mostgraph and MasterScreen-IOS
Acronym Evaluation of the respiratory resistance: Comparison between Mostgraph and MasterScreen-IOS
Scientific Title Evaluation of the respiratory resistance in patients with chronic respiratory diseases: Comparison between Mostgraph and MasterScreen-IOS
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kazuhisa Takahashi
Organization Juntendo University
Division name Department of Respiratory Medicine
Zip code
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
1st name
Middle name
Last name Mitsuaki Sekiya
Organization Juntendo University
Division name Department of Respiratory Medicine
Zip code
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

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)

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 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

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 Terminated
Date of protocol fixation
2012 Year 04 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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