UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001954 |
|---|---|
| Receipt number | R000002382 |
| Scientific Title | Evaluation of treatment to COPD by 320-area detector CT |
| Date of disclosure of the study information | 2009/05/11 |
| Last modified on | 2024/11/21 10:45:20 |
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Basic information
Public title
Evaluation of treatment to COPD by 320-area detector CT
Acronym
Evaluation of COPD by functional CT
Scientific Title
Evaluation of treatment to COPD by 320-area detector CT
Scientific Title:Acronym
Evaluation of COPD by functional CT
Region
| Japan |
Condition
Condition
obstructive respiratory disease
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of respiratory function of obstructive pulmonary disease by 320-area detector CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of ohysiological respiratory index and functional CT index
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
inhalation of bronchodialator and anti-inflammation drug
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COPD and bronchial asthma with FEV1.0<70%
Key exclusion criteria
the patients withou agreement of this study enroll
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6580072
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5111
kkoba@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-1 Kusunoki-cho Chuou-ku Kobe
TEL
078-382-5111
Homepage URL
kkoba@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-cho Chuou-ku Kobe
Tel
0783825111
kkoba@med.kobe-u.ac.jp
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
| 2009 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2212534513000130?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2212534513000130?via%3Dihub
Number of participants that the trial has enrolled
108
Results
Smokers showed an increased gap between the maximum and minimum R5 and X5 values incomparison with nonsmokers. Furthermore, R5 minus R20 was significantly higher in smokers. In smokers and COPD patients, the magnitude of expiratory X5 was more negative than that in nonsmokers. In smokers, R5 minus R20 was significantly higher than those in smokers.
Results date posted
| 2024 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ninety-two former and current smokers and 16 healthy volun
teers with no history of smoking
Participant flow
Using a commercial device (MostGraph01; CHEST MI. Inc.,Tokyo, Japan), we applied an intermittent hunning impulsesignal with a loud speaker and recorded mouth pressure and flow while the subjects were breathing at rest for 60s.
Adverse events
None
Outcome measures
We assessed and compared the impedance components, respiratory resistance, and　reactance in both the inspiratory and expiratory phases of nonsmokers, smokers, and COPD patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002382
