UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2011
Title of the study (Brief title)	Effect of Botulinum Toxin Type A Therapy in Patients with Japanese cedar pollinosis (E-BOAT study 3)
Region	Japan

Condition
Condition	Japanese cedar pollinosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of botulinum toxin type A in patients with Japanese cedar pollinosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Symptom score, Medication score, QOL estimation, Rhinomanometry
Key secondary outcomes	Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One ml (20U) of botulinum toxin type A is injected into each inferior turbinate during the season of Japanese cedar pollinosis. Loratadine (10 mg) and /or fluticason propionate nasal sprays can be used for severe nasal symptoms as a backup drug. Olopatadine hydrochloride eye drops can be used for eye symptoms.
Interventions/Control_2	One ml saline is injected into each inferior turbinate during the season of Japanese cedar pollinosis. Loratadine (10 mg) and /or fluticason propionate nasal sprays can be used for severe nasal symptoms as a backup drug. Olopatadine hydrochloride eye drops can be used for eye symptoms.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)a history of Japanese cedar pollinosis 2)CAP-RAST against Japanese cedar pollen >=2
Key exclusion criteria	1)pregnancy or possibility of pregnancy 2)history of heart disease 3)history of glaucoma 4)history of prostate hypertrophy 5)history of neuro-muscular disease 6)history of stroke 7)accompanying acute rhinitis or sinusitis 8)use of any anti-allergy drugs at the beginning of the study 9)history of nasal surgery 10)prominent deviation of the nasal septum
Target sample size	36

Research contact person
Name of lead principal investigator	keisuke Masuyama
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngoloty, Head and Neck Surgery
Address	1110 Shimokato, Chuou, Yamanashi, Japan
TEL	055-273-6769
Email	atkamijo@saitama-med.ac.jp

Public contact
Name of contact person	Atsushi Kamijo
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngoloty, Head and Neck Surgery
Address	1110 Shimokato, Chuou, Yamanashi, Japan
TEL	055-273-6769
Homepage URL
Email	akamijyo@yamanashi.ac.jp

Sponsor
Institute	Department of Otorhinolaryngoloty, Head and Neck Surgery Faculty of Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 08 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2011 Year 04 Month 01 Day
Date of closure to data entry	2011 Year 04 Month 01 Day
Date trial data considered complete	2011 Year 04 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

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

Management information
Registered date	2011 Year 01 Month 12 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005786