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 2017/05/15 11:56:41

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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

Email

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


Email

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


Email



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

Enrolling by invitation

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date


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

2017 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name