UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055293 |
|---|---|
| Receipt number | R000062081 |
| Scientific Title | Investigation of the number of oral bacteria and the conditions of COPD, asthma, and ACO |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2024/08/20 19:25:06 |
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Basic information
Public title
Investigation of the number of oral bacteria and the conditions of COPD, asthma, and ACO
Acronym
Oral bacteria in COPD and asthma
Scientific Title
Investigation of the number of oral bacteria and the conditions of COPD, asthma, and ACO
Scientific Title:Acronym
Oral bacteria in COPD and asthma
Region
| Japan |
Condition
Condition
COPD and asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the number of oral bacteria present in the conditions of COPD and asthma.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between number of oral bacteria and values of respiratory function test
Key secondary outcomes
Correlation between number of oral bacteria and values of symptom evaluation chart
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with COPD and asthma whose condition was stable.
Key exclusion criteria
Patients have attack symptoms of COPD or asthma, or whose other disease conditions were serious.
Target sample size
121
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Inui |
Organization
National Hospital Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
190-0014
Address
3256 Midoricho, Tachikawa City, Tokyo
TEL
0425265511
raicho_seven@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Inui |
Organization
National Hospital Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
190-0014
Address
3256 Midoricho, Tachikawa City, Tokyo
TEL
0425265511
Homepage URL
sakaguchi.dai.wg@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Disaster Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Disaster Medical Center
Address
3256 Midoricho, Tachikawa City, Tokyo
Tel
0425265511
sakaguchi.dai.wg@mail.hosp.go.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
| 2024 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
121
Results
In COPD patients, the number of oral bacteria had a significant negative correlation with respiratory function tests such as %FEV1, %PEF, and %FVC. In asthma patients, the number of oral bacteria had a significant negative correlation with respiratory function tests such as FEV1% and the increase in FEV1 in the reversibility test.
Results date posted
| 2024 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 50 cases of COPD, 32 cases of asthma, and 39 cases of ACO. The median ages were 72, 67, and 72 years, respectively, and the number of male participants was 41, 11, and 33, respectively.
Participant flow
Since this is an observational study, randomization was not performed.
Adverse events
Nothing in particular
Outcome measures
Correlation between the number of oral bacteria and various clinical data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | 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
We investigated the relationship between the number of oral bacteria and the severity of COPD and asthma in patients.
Management information
Registered date
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062081
