UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence on lower respiratory tract by the nosal provocation using the experimantal challenge chamber
Title of the study (Brief title)	Influence on lower respiratory tract by the nosal provocation
Region	Japan

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

Objectives
Narrative objectives1	To clarify whether the nasal provocation by Japanese cedar pollen is related to aggravation of function of the lower respiratory tract.
Basic objectives2	Others
Basic objectives -Others	To clarify the risk factor of aggravation of function of the lower respiratory tract.
Trial characteristics_1
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Change of FeNO and FEV1.0
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have medical history of cedar pollinosis for more than 2 years.
Key exclusion criteria	1)Asthma under treatment 2)Allergic rhinitis under treatment induced by other allergen 3)Complication of the other nasal-paranasal disease 4)Use of other antiallergic agent within 4 week 5)Pregnant women and those at risk of pregnancy
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Chiba University Graduate School
Division name	Department of Otorhinolaryngology
Address	1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL	043-222-7171
Email	jibika@office.chiba-u.jp

Public contact
Name of contact person	Syuji Yonekura
Organization	Chiba University Graduate School
Division name	Department of Otorhinolaryngology
Address	1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL	043-222-7171
Homepage URL
Email	jibika@office.chiba-u.jp

Sponsor
Institute	Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 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	The patients with Japanese cedar pollinosis are being recruted by an open call. Three hours pollen exposure for consecutive two days will be conducted. Changes of FeNO, FEV1.0 and nasal cavitiy resistance will be examined.

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021937