UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033047
Receipt No. 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 (Ver. 7)

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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
Institute Kurihara Central Hospital
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037679