UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and estimate of measuring exhaled nitric oxide levels in young children with asthma
Title of the study (Brief title)	FENOLA study
Region	Japan

Condition
Condition	asthma
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the feasibility of measuring FENO levels and to estimate how they reflect the control levels in asthmatic children 4-6 years of age
Basic objectives2	Others
Basic objectives -Others	To examine FENO measurement success rate by age and gender
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FENO measurement success rate by age and gender
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Niox Mino
Interventions/Control_2	EcoMedics CLD88
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	4 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	asthmatic children 4-6 years age
Key exclusion criteria	Children with wheeze except asthma Severely handicapped children Children with unstabel respiration
Target sample size	60

Research contact person
Name of lead principal investigator	Toshio Katsunuma
Organization	Daisan hospitai,jikei university
Division name	Depertment of Pediatrics
Address	4-11-1, Izumihoncho, Komae City, Tokyo
TEL	03-3480-1151
Email

Public contact
Name of contact person
Organization	Daisan hospitai,jikei university
Division name	Depertment of Pediatrics
Address
TEL
Homepage URL
Email	tkatsunuma@jikei.ac.jp

Sponsor
Institute	Department of Pediatrics, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Jikei University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 09 Month 15 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 29 Day
Last modified on	2016 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010565