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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002120
Receipt No. 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

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

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
URL(English) https://upload.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


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