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

* 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

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 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

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

Value
https://center6.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