UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Title of the study (Brief title)	Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Region	Japan

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

Objectives
Narrative objectives1	It is intended that I examine it in OHIO Chaber how you have an influence day after day again by time of the revelation how you have an influence on the onset of later nasal symptom by priming revelation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms score (Nasal)
Key secondary outcomes	1)Nasal secretion volume 2)Number of sneezing 3)Occurrence time of first nasal symptoms 4)Bitterness of the symptom(VAS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	14 subjects receive cedar pollen exposure in continuation (2hours,4hours,3hours or 2hours,6hours,4hours) for three days. The one week later, 14 subjects receive cedar pollen exposure equally in two days consecutive (4hours,3hours or 6hours,4hours).
Interventions/Control_2	14 subjects receive cedar pollen exposure in continuation (4hours,3hours or 6hours,4hours) for two days. The one week later, 14 subjects receive cedar pollen exposure equally in three days consecutive (2hours,4hours,3hours or 2hours,6hours,4hours).
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)CAPRAST score against Japanese cedar pollen over class 2 within the last 2 years. 2)Patient whom the nose symptom that was apparent to the cedar pollen scattering period this year developed in. 3)Written informed concent is required.
Key exclusion criteria	1)Patients with mucosal lesion of the nose and eyes. 2)Patients who received steroid injections within 6 months. 3) 4)Patients with respiratory disease such as asthma. 5)Patients with past history of anaphylaxis. 6)Patients who have receiving immunotherapy. 7)Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size	28

Research contact person
Name of lead principal investigator	Kazuhiro Hashiguchi
Organization	Futaba otolaryngology clinic
Division name	Futaba otolaryngology clinic
Address	Yotsuya Medical Bldg 2F.,20,Samoncho,Shinjuku-ku,Tokyo,Japan,160-0017
TEL	03-3351-4133
Email	k_hashiguchiiii@yahoo.co.jp

Public contact
Name of contact person	Satoko Shimizu
Organization	Tokyo Reserch Center of Clinical Pharmacology co.,ltd.
Division name	Customer Relations Dept.
Address	Yotsuya Medical Bldg 4F.,20,Samoncho,Shinjuku-ku,Tokyo,Japan,160-0017
TEL	03-5366-3454
Homepage URL
Email	s-shimizu@trcp.co.jp

Sponsor
Institute	Samoncho Clinic
Institute
Department

Funding Source
Organization	Samoncho Clinic
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	医療法人社団　信濃会　左門町クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 07 Day
Anticipated trial start date	2013 Year 05 Month 11 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	2013 Year 05 Month 07 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012392