UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022281 |
|---|---|
| Receipt number | R000025657 |
| Scientific Title | Research on gene expression regulated by long-term erythromycin therapy for chronic respiratory disease |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2024/11/18 21:12:17 |
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Basic information
Public title
Research on gene expression regulated by long-term erythromycin therapy for chronic respiratory disease
Acronym
Research on gene expression regulated by long-term erythromycin therapy for chronic respiratory disease
Scientific Title
Research on gene expression regulated by long-term erythromycin therapy for chronic respiratory disease
Scientific Title:Acronym
Research on gene expression regulated by long-term erythromycin therapy for chronic respiratory disease
Region
| Japan |
Condition
Condition
chronic respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the gene expression regulated by long-term erythromycin therapy for chronic respiratory disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
regulation of gene expression after 4~8 weeks treatment
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with chronic respiratory disease
2)Patients start to receive long-term erythromycin therapy
Key exclusion criteria
1)Patients who change their medicine except for erythromycin 1 month before treatment and 4~8 weeks after treatment
2)Patients who need to receive standard of care
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Keicho |
Organization
The Research Institute of Tuberculosis -Japan Anti-Tuberculosis Association
Division name
Department of Pathophysiology and Host Defense
Zip code
Address
3-1-24 Matsuyama, Kiyose, Tokyo 204-8533, Japan
TEL
042-492-4600
nkeicho@jata.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kozo Morimoto |
Organization
Fukujuji Hospital Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
Address
3-1-24 Matsuyama, Kiyose, Tokyo 204-8522, Japan
TEL
042-491-4111
Homepage URL
morimotok@fukujuji.org
Sponsor or person
Institute
Department of Pathophysiology and Host Defense, The Research Institute of Tuberculosis -Japan Anti-Tuberculosis Association
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Tuberculosis -Japan Anti-Tuberculosis Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are provided with samples of blood from patients who start long-term erythromycin therapy. RNA sequencing data from blood is used to analyze the changing transcriptome.
This research subjects patients who visit our hospital and meet our criteria after Jun.1, 2016.
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025657
