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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017046
Receipt No. R000019770
Scientific Title The effects of the oral care on the measurement of FeNO
Date of disclosure of the study information 2015/04/05
Last modified on 2015/04/04

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Basic information
Public title The effects of the oral care on the measurement of FeNO
Acronym Oral care and FeNO
Scientific Title The effects of the oral care on the measurement of FeNO
Scientific Title:Acronym Oral care and FeNO
Region
Japan

Condition
Condition healthy adults and asthma patients
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 FeNO is not a pure reflection of lower airway inflammation since it contains also NO originated from oral cavity. We evaluated the effect of oral care on the measurement of FeNO.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes FeNO change before and after the oral care.
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 The FeNO was measured at the time of awakening and before the bed in two consecutive days to investigate the diurnal variation of FeNO.In each time, the measurement was repeated three times, before the oral care, after gargling with water, finally after teeth brushing. NIOX MINO was used for 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
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy adults and asthma patients.
Those who can use NIOX-MINO for the measurement of FeNO.
Key exclusion criteria Those who cannot use NIOX-MINO for the measurement of FeNO.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Pulmonology Department
Zip code
Address Midorimachi 3256, Tachikawa, Tokyo, Japan
TEL 042-526-5511
Email tdmckamimura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Pulmonology Department
Zip code
Address Midorimachi 3256, Tachikawa, Tokyo, Japan
TEL 042-526-5511
Homepage URL
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center
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
2015 Year 04 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 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 04 Month 04 Day
Last modified on
2015 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019770

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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