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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003233
Receipt No. R000003045
Scientific Title The effect of topical steroid nasal spray, Mometasone Furoate Hydrate, on the slpeep sleep quality of pateints with perennial allergic rhinitis
Date of disclosure of the study information 2010/02/22
Last modified on 2011/02/22

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Basic information
Public title The effect of topical steroid nasal spray, Mometasone Furoate Hydrate, on the slpeep sleep quality of pateints with perennial allergic rhinitis
Acronym The effect of topical steroid nasal spray on the slpeep sleep quality of pateints with perennial allergic rhinitis
Scientific Title The effect of topical steroid nasal spray, Mometasone Furoate Hydrate, on the slpeep sleep quality of pateints with perennial allergic rhinitis
Scientific Title:Acronym The effect of topical steroid nasal spray on the slpeep sleep quality of pateints with perennial allergic rhinitis
Region
Japan

Condition
Condition perennial allergic rhinitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the efficacy of topical nasal steroid in treating patients for the symptoms including sleep quality of perennial allergic rhinitis. In this study, we also measure the concetration of ntric oxide in the upper or lower airways, undertaken to determine the association with the symptoms and sleep quality of perennial allergic rhinitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Efficacy of topical nasal steroid
Key secondary outcomes Concentration of nitric oxide in the upper or lower airways

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 NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 It is given the intranasal spray containing topical steroid (Mometasone Furoate Hydrate), once per day (two pushes once) for 14days.
Interventions/Control_2 It is given the intranasal spray containing placebo materials once per day (two sprays once) for 14days.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria CAP-RAST against the antigens causing for perennial allergy over class 2, with symptons of allergic rhinitis
Key exclusion criteria Prgnancy, potential pregnancy, and breast-feeding patient.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeharu Fujieda
Organization Faculty of medicine, University of Fukui
Division name Department of Otorhinolaryngology
Zip code
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji, Yoshida, Fukui, 910-1193, Japan
TEL 0776-61-8407
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takechiyo Yamada
Organization Faculty of medicine, University of Fukui
Division name Department of Otorhinolaryngology
Zip code
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji, Yoshida, Fukui, 910-1193, Japan
TEL 0776-61-8407
Homepage URL
Email ymdtkcy@u-fukui.ac.jp

Sponsor
Institute Faculty of medicine, University of Fukui
Institute
Department

Funding Source
Organization Department of Otorhinolaryngology, Faculty of medicine, University of Fukui
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2009 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 22 Day
Last modified on
2011 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003045

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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