UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Determination of the effect of topical glucorticosteroid on the barrier function of human nasal mucosa
Title of the study (Brief title)	Effects of topical glucorticosteroid on the human nasal barrier
Region	Japan

Condition
Condition	allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To detect the effect of topical glucocorticoid, pre and post nasal provocation on nasal mucosal barrier
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	nasal transepithelial water loss, nasal potential differences
Key secondary outcomes	clinical symptoms

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	fluticasone furoate
Interventions/Control_2	fluticasone furoate placebo
Interventions/Control_3	mometasone furoate
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Japanese cedar poliinosis
Key exclusion criteria	allergic rhinitis with active inflammation
Target sample size	1

Research contact person
Name of lead principal investigator	masato miwa
Organization	Juntendo Universiry
Division name	Otorhinolaryngology
Address	3-1-3 Hongo Bunkyo Tokyo
TEL	03-5802-1229
Email	mmiwa@juntendo.ac.jp

Public contact
Name of contact person	masato miwa
Organization	Juntendo Universiry
Division name	Otorhinolaryngology
Address	3-1-3 Hongo Bunkyo Tokyo
TEL	03-5802-1229
Homepage URL
Email	mmiwa@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 03 Month 22 Day
Anticipated trial start date	2013 Year 03 Month 22 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 01 Month 31 Day
Date trial data considered complete	2014 Year 02 Month 28 Day
Date analysis concluded	2014 Year 05 Month 31 Day

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

Management information
Registered date	2013 Year 04 Month 12 Day
Last modified on	2017 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012241