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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029653
Receipt No. R000033885
Scientific Title Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber)
Date of disclosure of the study information 2017/10/22
Last modified on 2019/02/19

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Basic information
Public title Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber)
Acronym Comparison of an effect of the antihistaminesfor Japanese cedar pollinosis
Scientific Title Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber)
Scientific Title:Acronym Comparison of an effect of the antihistaminesfor Japanese cedar pollinosis
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 the difference of an effect of the second generation antihistamines with different configuration (desloratadine and levocetirizine) for Japanese cedar pollinosis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total nasal symptom score when Japanese cedar pollen exposition was performed for 3 hours in the environmental challrenge chamber
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group which took desloratadine (5mg)on the day before of pollen exposition
Interventions/Control_2 The group which took levocetirizine (5mg) on the day before of pollen exposition
Interventions/Control_3 The group which took placebo on the day before of pollen exposition
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)Patients who have medical history of cedar pollinosis for more than 2 years.
2)Patients who do not have nasal symtoms induced by any allergen and requier any drug treatment out of Japanese cedar pollen scattering season.
3)Positive specific IgE to cedar pollen allergen(>=class2)
4)Patients who develop more tha derate symptoms by a pollen exposure for 3 hours.
Key exclusion criteria 1) Drug allergy for antihistaines including intervention medicines
2) Patinets with allergic rhinitis to require treatment in non-scattering period of Japanese cedar pollen
3) Patients with nasal disease that affects the evaluation of the study
4) Severe respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease
5) Pregnant women and those at risk of pregnancy
6) Women who are planning pregnancy
7) Lactating woman
8) Patients treated with anti-allergic drugs within 2 week of screening
9) The patients who the doctor judged inappropriate for the study
Target sample size 50

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

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

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

Funding Source
Organization KYORIN Holdings, Inc.
Organization
Division
Category of Funding Organization Profit 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
2017 Year 10 Month 22 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
50 cases participaterd in the trial. In comparison with a placebo, total nasal symptom score, a primaly end point, were lowere in desloratadine and levocetirizine groups. However, the statistical significant difference between desloratadine and levocetiridize was not clear.
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 Completed
Date of protocol fixation
2017 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 23 Day
Date analysis concluded
2018 Year 06 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 22 Day
Last modified on
2019 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033885

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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