UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009821
Receipt number R000011412
Scientific Title Airway biomarkers and air pollution in patients with asthma and other airway diseases
Date of disclosure of the study information 2013/01/22
Last modified on 2020/01/16 10:59:43

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Basic information

Public title

Airway biomarkers and air pollution in patients with asthma and other airway diseases

Acronym

Airway biomarkers and pollution

Scientific Title

Airway biomarkers and air pollution in patients with asthma and other airway diseases

Scientific Title:Acronym

Airway biomarkers and pollution

Region

Japan


Condition

Condition

bronchial asthma and other respiratoroy diseaseas, sharing some clinical manifestation.

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

We so far demonstrated that Nrf-1, or a transcription factor regulating expression of anti-oxidant-associated genes, is a good biomarker for airway inflammation, and that it is associated with environmental pollution. The aim of this study is to clarify how these baiomarkers, polymorphism of anti-oxidant genes, and environmental pollution are associated with pathogenesis of asthma and other airway disaeses.

Basic objectives2

Others

Basic objectives -Others

Effect of air pollution on the airway is to be evaluated: biomarkers for cytokines, growth factors, and oxidative stress in exhaled breath condensates and blood, are measured. In addtion, polymorphisms of genes responding to oxidative stress are determined. It is also defined how much environmental air is polluted in participants' residential area. General and clinical indicators of asthma and its control are also evaluated. By assessing these biomarkers and data togeter, the study aims at description of how environmental air affect the airway inflammation, and of which is associated with development of asthma or other diseases.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

(1) Air pollution
(2) general assessment of asthma and airway inflammation
(3) genetic polymorphism
Association between them is investigated.

Key secondary outcomes

In addition to the above mentioned intems, the following items is investigated, indcluidng
(1) mediators in EBC
(2) mediators in blood
(3) oxidative stress of EBC and blood
(4) inflammatory biomarkers


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

Participants are those who were already diagnosed or suspected with asthma, those who chronically complain respiratory symptoms such as cough, those who were allergic with no symptoms, and those who might be other diseases with respiratopry symptoms including COPD, lung cancer and disseminated lung diseases, as well as healthy individuals. In this process, internationa primary care airway group (IPAG) quesstionairres and other questionnairres will be utilized. They should be twenty years old or over and give informed consent on the basis that the study is approved by each local ethics committee.

Key exclusion criteria

Those whe are dianosed with pulmonary infection, severe cardiologic, hepatic and/or renal issues, are to be excluded. This decision is to be made according by physicians in charge.



Target sample size

280


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Takizzawa

Organization

Kyorin University School of Medicine

Division name

Department of Respiratyry Medicine

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Email

htakizawa-alg@umin.ac.jp


Public contact

Name of contact person

1st name Kazuki
Middle name
Last name Tabata

Organization

Kyorin University

Division name

Ethical Committee

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Homepage URL


Email

irb@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University Shool of Medicine

Institute

Department

Personal name



Funding Source

Organization

Environmental Restoration and Conservation Agency

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

Kyorin University

Address

6-20-2,Shinkawa,Mitaka-shi,Tokyo 181-8611 JAPAN

Tel

0422-47-5511

Email

irb@ks.kyorin-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

2013 Year 01 Month 22 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

106

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

2012 Year 10 Month 30 Day

Date of IRB

2012 Year 10 Month 15 Day

Anticipated trial start date

2012 Year 12 Month 22 Day

Last follow-up date

2019 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is cross-sectional prospective observational one, which is intended to clarify how air pollution induces airway inflammation, and, what is more, how genetic polymorphism modifies it.


Management information

Registered date

2013 Year 01 Month 20 Day

Last modified on

2020 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name