UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007876 |
|---|---|
| Receipt number | 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 00:31:30 |
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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
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
msekiya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009257
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
