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
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
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
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
