UMIN-CTR Clinical Trial

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 Junpei Middle name Last name Saito
Organization	Fukushima Medical University, School of Medicine
Division name	Department of Pulmonary Medicine
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima city, Fukushima Prefecture
TEL	08045151971
Email	junpei@fmu.ac.jp

Public contact
Name of contact person	1st name Junpei Middle name Last name Saito
Organization	Doctor
Division name	Department of Pulmonary Medicine
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima city, Fukushima Prefecture
TEL	08045151971
Homepage URL
Email	junpei@fmu.ac.jp

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	Ethics committee of Fukushima Medical Uiversity
Address	1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel	024- 547-1825
Email	fmucrb@fmu.ac.jp

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	Completed
Date of protocol fixation	2013 Year 05 Month 09 Day
Date of IRB	2013 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 12 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 31 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2023 Year 01 Month 31 Day

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	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012481