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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032497
Receipt No. 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 2019/05/24

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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
Middle name
Last name Yoshihiro Kanemitsu
Organization Nagoya City University School of Medical Sciences
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-853-8216
Email m-take19@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Takemura
Organization Nagoya City University School of Medical Sciences
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-853-8216
Homepage URL
Email m-take19@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University School of Medical Sciences
Department of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department

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 JA Aichi Welfare association, Kainan Hospital
Independent Administrative Institution Labor Health and Safety Organization, Asahi Rosai Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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