UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050691 |
|---|---|
| Receipt number | R000057747 |
| Scientific Title | Low dose macrolide used in stable COPD |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2024/03/14 09:46:24 |
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Basic information
Public title
Low dose macrolide used in stable COPD
Acronym
macrolide used in stable COPD
Scientific Title
Low dose macrolide used in stable COPD
Scientific Title:Acronym
Low dose macrolide used in stable COPD
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
check the efficiency of macrolide in COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COPD execerbation
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. COPD
2. Macrolide used
Key exclusion criteria
1. COPD acute phase
2. short term usage of macrolide
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama Minami Kyousai Hospital
Division name
Chemotherapy department
Zip code
236-0037
Address
1-21 Rokufuhigashi Kanazawa Yokohama
TEL
045-782-2101
chinsmd@gmail.com
Public contact
Name of contact person
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama Minami Kyousai Hospital
Division name
Chemotheraoy Department
Zip code
236-0037
Address
Yokohama Minami Kyousai Hospital
TEL
045-782-2101
Homepage URL
chinsmd@gmail.com
Sponsor or person
Institute
Yokohama City Uiversity
Institute
Department
Personal name
Hao Chen
Funding Source
Organization
Yokohama City University
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
Yokohama City University Hospital
Address
3-9 Fukuura Kanazawa yokohama City
Tel
045-787-2800
chinsmd@gmail.com
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
| 2023 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
400
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 27 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 27 | Day |
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057747
