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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010675
Receipt No. R000012481
Scientific Title The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control
Date of disclosure of the study information 2013/06/11
Last modified on 2013/05/08

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Basic information
Public title The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control
Acronym Asthma control using fractional exhaled nitric oxide (FeNO)
Scientific Title The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control
Scientific Title:Acronym Asthma control using fractional exhaled nitric oxide (FeNO)
Region
Japan

Condition
Condition - Bronchial asthma with no treatment
- Healthy non-smoker
Classification by specialty
Pneumology Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to observe the timecourse of FeNO levels in asthmatic subjects.
Basic objectives2 Others
Basic objectives -Others Daily FeNO measurements will be perfoemed to see whether there is a day-to-day, or week-to-week fluctuation in FeNO levels in asthmatic subjects before and after asthma treatment.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To compare diurnal variations and week-to-week variations of FeNO levels in asthmatic subjects before and after asthma treatment
Key secondary outcomes To compare whether there are diurnal and week-to-week variations of FeNO levels in asthmatic subjects when they are devided into controlled and uncontrolled state.

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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Asthmatic patients at the outpatient clinic at Fukushima Medical University Hospital who have not yet been treated for asthma.
In addition, healthy non-smoking volunteers
Key exclusion criteria 1. Patients with respiratory diseases other than asthma.
2. Pregnant women or breast feeding women
3. Patients who are unable to give informed consent.
4. Inappropriate patients judged by respiratory physician.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junpei Saito
Organization Fukushima Medical University, School of Medicine
Division name Department of Pulmonary Medicine
Zip code
Address 1 Hikarigaoka, Fukushima city, Fukushima Prefecture
TEL 024-547-1360
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junpei Saito
Organization Fukushima Medical University, School of Medicine
Division name Department of Pulmonary Medicine
Zip code
Address 1 Hikarigaoka, Fukushima city, Fukushima Prefecture
TEL 024-548-2111
Homepage URL
Email

Sponsor
Institute Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine
Institute
Department

Funding Source
Organization Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine
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 福島県立医科大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 11 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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Daily FeNO measurements will be perfoemed to see whether there is a day-to-day, or week-to-week fluctuation in FeNO levels in asthmatic subjects before and after asthma treatment.

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2013 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012481

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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