UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011740 |
|---|---|
| Receipt number | R000013726 |
| Scientific Title | The effectiveness of Fluticasone furoate for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance. |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2013/09/12 22:03:45 |
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Basic information
Public title
The effectiveness of Fluticasone furoate for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance.
Acronym
The effectiveness of Fluticasone furoate for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance.
Scientific Title
The effectiveness of Fluticasone furoate for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance.
Scientific Title:Acronym
The effectiveness of Fluticasone furoate for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance.
Region
| Japan |
Condition
Condition
allergic rhinitis, sleep disturbance
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether Fluticasone furoate is effective in treating for pediatric allergic rhinitis patients with nasal obstruction and sleep disturbance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA18
Key secondary outcomes
Children's Sleep Habit Questionnaire Japan (CSHQ-J)
sleep study
rhinoscopic findings score
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)washout
2)Fluticasone furoate 27.5ug spray each nasalcavity once/day 4 weeks
3)evaluate on within 3 days after final medication
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
| 2 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
diagnosed as a sleep distuabance within one month before trial
Key exclusion criteria
1)patient who need oral steroid intake
2)hypersensitivity for Fluticasone furoate
3)The patient who is judged as inappropriate for the study by doctor
4)infectious disease without effective antibiotics, patient of the deep seated mycosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamashita |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Otolaryngology,
Zip code
Address
1-1-1 minami kogushi, Ube
TEL
0836-22-2281
hiro-shi@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Hara |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
1-1-1 minami kogushi, Ube
TEL
0836-22-2281
Homepage URL
harahiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
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
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
| 2013 | Year | 09 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2013 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013726
