UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032497 |
|---|---|
| Receipt number | R000037057 |
| Scientific Title | The risk of pneumonia and hospitalization in patients with chronic abstructive pulmonary disease |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2020/05/08 11:35:39 |
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Basic information
Public title
The risk of pneumonia and hospitalization in patients with chronic abstructive pulmonary disease
Acronym
The risk of pneumonia and hospitalization in patients with COPD
Scientific Title
The risk of pneumonia and hospitalization in patients with chronic abstructive pulmonary disease
Scientific Title:Acronym
The risk of pneumonia and hospitalization in patients with COPD
Region
| Japan |
Condition
Condition
chronic abstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will research on COPD pneumonia and hospitalized patients from the viewpoint of cough symptoms and cough sensitivity to identify risk factors, leading to the establishment of future preventive measures.
Basic objectives2
Others
Basic objectives -Others
We will examine whether the results of the previous report can be reproduced on the frequency of exacerbations of COPD or whether hospitalization due to exacerbation is related to cough sensitivity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the history of pneumonia and the history of hospitalization related to COPD from patients with COPD in relation to cough sensitivity
Key secondary outcomes
Clinical indicators other than cough sensitivity related to pneumonia, exacerbation, hospitalization in patients with COPD (presence or absence of asthma complication, cardiac function, spinal column standing muscle volume, serum IgE, BNP, etc.)
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
1)COPD patients (including cases of asthma combined) who were consulted or hospitalized at respiratory department of the hospital from January 2018 to March 2021
2)Patients who have written consent from the patient himself about participation in this study
Key exclusion criteria
1)Patients with less frequent hospital visits which are difficult to follow progress
2)Patients with complications of other obvious respiratory diseases such as interstitial lung disease
3)Minor
4)Patients who are judged inappropriate as the subject by the research director
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
m-take19@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Takemura |
Organization
Nagoya City University School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
Homepage URL
m-take19@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University School of Medical Sciences
Department of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University School of Medical Sciences
Department of Respiratory Medicine, Allergy and Clinical Immunology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka general hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital Clinical Trial Management Center
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2018 | Year | 05 | Month | 08 | 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
| 2018 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
April 26, 2018 Approval of in-campus ethics review
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037057
