UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003233 |
|---|---|
| Receipt number | 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 06:07:48 |
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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
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
ymdtkcy@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of medicine, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003045
