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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007157
Receipt No. R000008431
Scientific Title Effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of patients with pollinosis
Date of disclosure of the study information 2012/03/01
Last modified on 2012/07/30

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Basic information
Public title Effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of patients with pollinosis
Acronym Effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of patients with pollinosis
Scientific Title Effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of patients with pollinosis
Scientific Title:Acronym Effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of patients with pollinosis
Region
Japan

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

Objectives
Narrative objectives1 In the present study, an attempt is made to examine effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of subjects who have a history of allergic rhinitis symptoms during the pollen season. For this purpose, we use an environmental exposure unit and exposed the subjects to 8000 counts/m3 of Japanese cedar pollen for 3 hours in the off-season. Changes in expression of histamine H1 receptor and allergy-related cytokine mRNA in the nasal mucosa are examined.
Basic objectives2 Others
Basic objectives -Others In the present study, an attempt is made to examine effects of artificial exposure of Japanese cedar pollen on expression of histamine H1 receptor mRNA in the nasal mucosa of subjects who have a history of allergic rhinitis symptoms during the pollen season. For this purpose, we use an environmental exposure unit and exposed the subjects to 8000 counts/m3 of Japanese cedar pollen for 3 hours in the off-season. Changes in expression of histamine H1 receptor and allergy-related cytokine mRNA in the nasal mucosa are examined.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The expression of histamine H1 receptor and allergy-related cytokine mRNA in the nasal mucosa
Key secondary outcomes The allergic rhinitis symptoms including sneezing, nasal discharge and nasal obstruction

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Artificial exposure of Japanese cedar pollen
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

Not applicable
Gender Male and Female
Key inclusion criteria Adult subjects have a history of allergic rhinitis symptoms such as sneezing, nasal discharge and nasal obstruction during the pollen season
Key exclusion criteria Patients who was excluded by investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Takeda
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address 3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization Grant-in-Aid from Ministry of Health and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 28 Day
Last modified on
2012 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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