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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004930
Receipt No. R000005868
Scientific Title Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Date of disclosure of the study information 2011/01/22
Last modified on 2011/01/22

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Basic information
Public title Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Acronym Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Scientific Title Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Scientific Title:Acronym Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Region
Japan

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

Objectives
Narrative objectives1 This study is a prospective single-center,randomized,parallel-group study comparing the effects of initial treatment with Fluticasone Furoate and Fexofenadine hydrochloride
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Total nasal symptom score
Key secondary outcomes Total ocular symptom score,
Japan Rhinoconjunctivitis QOL Questionaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fluticasone furoate puff per nostril once a day 110µg is administered as initial treatment for Japanese cedar pollinosis.
60mg of Fexofenadine orally twice a day can be used as a backup drug.
Interventions/Control_2 60mg of Fexofenadine orally twice a day is administered as initial treatment for Japanese cedar pollinosis.
Fluticasone furoate puff per nostril once a day 110µg can be used as a backup drug.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed with Japanese cedar pollinosis and who desire initial therapy and meet following requirements
1)A history of Japanese cedar pollinosis for at least one season before study entry
2)patient can write down the pollinosis-dairy of this study appropriately from the doctor's viewpoint
3)patient can keep the rule of this study and doctor's direction from the doctor's viewpoint
4)obtain informed consent before registration to this study
5)Patient aged 15 years and above when doctors obtain informed consent
Key exclusion criteria 1)patient experienced adverse effect by components of study drug
2)patients who is pregnant or suspected of pregnancy , wish to get pregnant , nursing mom
3)inappropriate patient for this study from the doctor's viewpoint
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikiya Asako
Organization Kansai Medical University Hirakata Hospital
Division name Otolaryngology Head and neck surgery
Zip code
Address 2-3-1shinmachi,hirakata,osaka
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mikiya Asako
Organization Kansai Medical University Hirakata Hospital
Division name Otolaryngology Head and neck surgery
Zip code
Address 2-3-1shinmachi,hirakata,osaka
TEL 072-804-0101
Homepage URL
Email

Sponsor
Institute Kansai Medical University
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)

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
2011 Year 01 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
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 Preinitiation
Date of protocol fixation
2010 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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
2011 Year 01 Month 22 Day
Last modified on
2011 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005868

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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