UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033047
Receipt number R000037679
Scientific Title Study on the factors related to pneumonia and exacerbation in patients with chronic obstructive pulmonary disease (COPD)
Date of disclosure of the study information 2018/06/19
Last modified on 2020/06/23 07:04:48

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Basic information

Public title

Study on the factors related to pneumonia and exacerbation in patients with chronic obstructive pulmonary disease (COPD)

Acronym

Study on the factors related to pneumonia and exacerbation in patients with chronic obstructive pulmonary disease (COPD)

Scientific Title

Study on the factors related to pneumonia and exacerbation in patients with chronic obstructive pulmonary disease (COPD)

Scientific Title:Acronym

Study on the factors related to pneumonia and exacerbation in patients with chronic obstructive pulmonary disease (COPD)

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the risk factors related to pneumonia and exacerbation in patients with COPD.

Basic objectives2

Others

Basic objectives -Others

To study the risk factors in patients with COPD related to develop,emt of pneumonia and exacerbation.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

serum albumin

Key secondary outcomes

serum protein concentration, body weight, respiratory function


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

110 years-old >=

Gender

Male and Female

Key inclusion criteria

COPD patients

Key exclusion criteria

No

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Usami

Organization

Kurihara Central Hospital

Division name

Department of Internal Medicine

Zip code

987-2205

Address

3-1-1 Tsukisate-Miyano-chuo, Kurihara City, Miyagi Prefecture, Japan

TEL

0228315330

Email

sugarponta@icloud.com


Public contact

Name of contact person

1st name Mutsuo
Middle name
Last name Yamaya

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Advanced Preventive Medicine for Infectious Disease

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan

TEL

0227177184

Homepage URL


Email

myamaya@med.tohoku.ac.jp


Sponsor or person

Institute

Kurihara Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Kurihara Central Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kurihara Central Hospital Ethics Committee

Address

3-1-1 Tsukisate-Miyano-chuo, Kurihara City, Miyagi Prefecture, 987-2205, Japan

Tel

0228-21-5330

Email

masaaki-ooba@kam.or.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 06 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

156

Results

In the exacerbation group (n=60), the values of pulmonary function test, including FVC and FEV1, and serum total protein and albumin concentrations were lower, and COPD severity rankings, and proportions of patients with severe emphysema and receiving long-term oxygen therapy were higher than those in the nonexacerbation group (n=76). In the multivariate analysis, the risk factors were hypoalbuminemia, hypoproteinemia and low FEV1.

Results date posted

2019 Year 12 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

No

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 02 Month 06 Day

Date of IRB

2018 Year 03 Month 19 Day

Anticipated trial start date

2018 Year 03 Month 19 Day

Last follow-up date

2019 Year 12 Month 20 Day

Date of closure to data entry

2020 Year 03 Month 10 Day

Date trial data considered complete

2020 Year 03 Month 10 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

We will examine the risk factors associated with development of pneumonia and exacerbation during treatment of COPD patients, including serum albumin and pulmonary function.


Management information

Registered date

2018 Year 06 Month 19 Day

Last modified on

2020 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name