UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031509
Receipt number R000035977
Scientific Title Study on mortality of asthmatic patients with airflow obstruction based on cohort of air pollution-related respiratory diseases in Omuta city
Date of disclosure of the study information 2018/03/01
Last modified on 2019/07/11 09:49:35

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Basic information

Public title

Study on mortality of asthmatic patients with airflow obstruction based on cohort of air pollution-related respiratory diseases in Omuta city

Acronym

Study on mortality of asthma with airflow obstruction

Scientific Title

Study on mortality of asthmatic patients with airflow obstruction based on cohort of air pollution-related respiratory diseases in Omuta city

Scientific Title:Acronym

Study on mortality of asthma with airflow obstruction

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate mortality of asthmatic patients with airflow obstruction

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mortality

Key secondary outcomes

cause of death


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


Not applicable

Gender

Male and Female

Key inclusion criteria

asthma

Key exclusion criteria

other respiratory diseases

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Tomotaka
Middle name
Last name Kawayama

Organization

Kurume University

Division name

Department of medicine

Zip code

830-0011

Address

67 Asahimachi, Kurume

TEL

0942-31-7560

Email

kawayama_tomotaka@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name Tomotaka
Middle name
Last name Kawayama

Organization

Kurume University

Division name

Department of medicine

Zip code

830-0011

Address

67 Asahimachi, Kurume

TEL

0942-31-7560

Homepage URL


Email

kawayama_tomotaka@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University

Institute

Department

Personal name



Funding Source

Organization

Kurume 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

Kurume University

Address

67 Asahimachi, Kurume

Tel

0942-35-3311

Email

sangakuml@kurume-u.ac.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 03 Month 01 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

697

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

2015 Year 09 Month 11 Day

Date of IRB

2015 Year 09 Month 11 Day

Anticipated trial start date

2018 Year 02 Month 28 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 08 Month 31 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information

Cohort study


Management information

Registered date

2018 Year 02 Month 28 Day

Last modified on

2019 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035977


Research Plan
Registered date File name
2019/07/11 ① 大牟田公害認定患者の予後調査_久留米大学倫理員会申請書類_09012015.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name