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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011740
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email harahiro@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013726


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