UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of add-on medication (with dose increase, combined with anti-leukotriene , combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Title of the study (Brief title)	Effect of add-on medication (with dose increase, combined with anti-leukotriene , combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Region	Japan

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

Objectives
Narrative objectives1	Examination of the effect of add-on medication (with dose increase,combined with anti-leukotriene,combined with steroid nasal spray) for allergic patients .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Assesment of symptom after as below for the allergic rhinitis patients . Allergic rhinitis patients are separeted 3groups(dose increase,combined with anti-luekotriene, combined with steroid nasal spray) ,and carry on for 4 week. Assesment:medical examination at the department of otorhinolaryngology with a disease questionnaire.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1Double dose , 2used together with anti leuotorien,3used together with steroid nasal spray
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	allergoc rhinitis
Key exclusion criteria	Patients judged inappropriate for this study by the physicians
Target sample size	150

Research contact person
Name of lead principal investigator	Nibu Keni-chi
Organization	Kobe University Graduate Scool of Medicine
Division name	Department of otorhinolaryngology Head and Neck Surgery
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL	81-78-382-5111
Email	nibu@med.kobe-u.ac.jp

Public contact
Name of contact person	Nibu Keni-chi
Organization	Kobe University Graduate Scool of Medicine
Division name	Department of otorhinolaryngology Head and Neck Surgery
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL	81-78-382-5111
Homepage URL	http://www.hosp.kobe-u.ac.jp/chiken/OOchiken_top.htm
Email	nibu@med.kobe-u.ac.jp

Sponsor
Institute	Graduate Scool of Medicine
Institute
Department

Funding Source
Organization	Graduate Scool of Medicine Department of otorhinolaryngology Head and Neck Surgery
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 22 Day
Anticipated trial start date	2013 Year 09 Month 18 Day
Last follow-up date	2014 Year 07 Month 31 Day
Date of closure to data entry	2014 Year 07 Month 31 Day
Date trial data considered complete	2014 Year 07 Month 31 Day
Date analysis concluded	2014 Year 07 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 07 Month 31 Day
Last modified on	2016 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013187