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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name