UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037057