UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020726 |
|---|---|
| Receipt number | R000023838 |
| Scientific Title | Role of inflammatory cells in the pathophysiology of obstructive pulmonary disease (COPD and bronchial asthma) |
| Date of disclosure of the study information | 2016/01/28 |
| Last modified on | 2023/08/02 14:27:56 |
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Basic information
Public title
Role of inflammatory cells in the pathophysiology of obstructive pulmonary disease (COPD and bronchial asthma)
Acronym
Role of inflammatory cells in the pathophysiology of obstructive pulmonary disease
Scientific Title
Role of inflammatory cells in the pathophysiology of obstructive pulmonary disease (COPD and bronchial asthma)
Scientific Title:Acronym
Role of inflammatory cells in the pathophysiology of obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Choronic obstructive pulmonary disease, bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the role of inflammatory cells in the pathophysiology of obstructive pulmorary deisease.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the role of inflammatory cells in the pathophysiology of obstructive pulmorary deisease, especially focusing on innate immunity.
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
COPD and bronchial asthma patients diagnosed by spirometry and their symptoms, and healthy volunteers
Key exclusion criteria
patients and healthy volunteers who deny participating in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Aizawa |
Organization
Tohoku University Graduate school of medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8539
hiroyuki-aizawa@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Aizawa |
Organization
Tohoku University Graduate school of medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8539
Homepage URL
hiroyuki-aizawa@rm.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine,
Tohoku University Graduate School of
Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Novartis Pharma K.K.
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2016 | Year | 01 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design : case-control study study
subjects recruitment method : all subjects
who admit to our hospital since May 2013 and
meet the selection criteria and who apply to
pubilic offering.
mesurement items : lung function, blood samples, sputum samples, expired gas analysis, exhaled breath condensate
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023838
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
