UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019953
Receipt number R000023040
Scientific Title The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Date of disclosure of the study information 2015/11/27
Last modified on 2017/05/10 19:46:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Acronym

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Scientific Title

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Scientific Title:Acronym

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Region

Japan


Condition

Condition

respiratory disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Basic objectives2

Others

Basic objectives -Others

The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

correlation between exhaled nitric oxide and several parameters

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

mesurements of a fraction of exhaled nitric oxide

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

0 years-old <=

Age-upper limit

120 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy control and patients suffering from bronchial asthma, COPD, interstitial pneumonia, drug induced lung disease, lung cancer, radiation pneumonia, acute pneumonia, bronchiectasis and sarcoidosis.

Key exclusion criteria

patients with hemoptysis

Target sample size

780


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Hasegawa

Organization

Nagoya University

Division name

respiratory medicine

Zip code


Address

65 tsurumai syowaku Nagoya

TEL

0527442167

Email

yhasega@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Wakahara

Organization

Nagoya University

Division name

respiratory medicine

Zip code


Address

65 tsurumai syowaku Nagoya

TEL

0527442167

Homepage URL


Email

wakahara@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya 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


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

2015 Year 11 Month 27 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

2015 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 27 Day

Last modified on

2017 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name