UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028913 |
|---|---|
| Receipt number | R000033077 |
| Scientific Title | Evaluation of respiratory mechanics in patients with obstructive lung diseases |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2018/12/13 09:17:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of respiratory mechanics in patients with obstructive lung diseases
Acronym
Evaluation of respiratory mechanics in patients with obstructive lung diseases
Scientific Title
Evaluation of respiratory mechanics in patients with obstructive lung diseases
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu university school of medicine
Division name
The second division, department of internal medicine
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Niwa |
Organization
Hamamatsu university school of medicine
Division name
The second division, department of internal medicine
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL
053-435-2263
Homepage URL
mtr.nw@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033077
