UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002120
Receipt number R000002582
Scientific Title Fractional exhaled nitric oxidein patients with idiopathic pulmonary fibrosis
Date of disclosure of the study information 2009/06/24
Last modified on 2009/12/24 15:23:23

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Basic information

Public title

Fractional exhaled nitric oxidein patients with idiopathic pulmonary fibrosis

Acronym

Fractional exhaled nitric oxidein patients with idiopathic pulmonary fibrosis

Scientific Title

Fractional exhaled nitric oxidein patients with idiopathic pulmonary fibrosis

Scientific Title:Acronym

Fractional exhaled nitric oxidein patients with idiopathic pulmonary fibrosis

Region

Japan


Condition

Condition

idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the FeNO levels and examine whether initial FeNO level correlated with conventional parameters in IPF patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between the FeNO level and conventional 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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

The measurement of FeNO

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

Idiopathic pulmonary fibrosis patients
Patients are not under systemic steroid or immunosuppressive therapy

Key exclusion criteria

Cases with collagen vascular disease
Cases with pulmonary hypertension
Cases with other forms of interstitial lung diseases
Cases in disease exacerbation
CAses with systemic steroid or immunosuppressive therapy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kingo Chida

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address

1-20-1 Handayama, Hamamatsu, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masato Kato

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

2009 Year 06 Month 24 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

2008 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2009 Year 12 Month 01 Day

Date trial data considered complete

2009 Year 12 Month 01 Day

Date analysis concluded

2009 Year 12 Month 01 Day


Other

Other related information

prospective
items:pulmonary function test, laboratory data, clinical data


Management information

Registered date

2009 Year 06 Month 24 Day

Last modified on

2009 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name