UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012861
Receipt number R000015003
Scientific Title A double-blind, placebo-controlled, single-center, randomized, parallel-group clinical trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis.
Date of disclosure of the study information 2014/01/15
Last modified on 2016/09/22 12:18:34

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Basic information

Public title

A double-blind, placebo-controlled, single-center, randomized, parallel-group clinical trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis.

Acronym

Clinical Trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis

Scientific Title

A double-blind, placebo-controlled, single-center, randomized, parallel-group clinical trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis.

Scientific Title:Acronym

Clinical Trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the approriate timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Total nasal symptom score (the sum of the severity score of 4 daily nasal symptoms; itchy nose, runny nose, stuffy nose, and sneezing. score range 0-12.)

Key secondary outcomes

Rhinoconjunctivitis QOL Questionaire score(RQLQ,JRQLQ), The Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Total ocular symptom score, mRNA expression on nasal mucosa


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Fluticasone furoate puff per nostril once a day 110 micro gram is administered from 1st Feb.
60mg of fexofenadine orally twice a day can be used as a backup drug.

Interventions/Control_2

Placebo dreg puff per nostril once a day is administered from 1st Feb.
Fluticasone furoate puff per nostril once a day 110 micro gram is administered from the beginning of pollinosis.
60mg of fexofenadine orally twice a day can be used as a backup drug.





Interventions/Control_3

Placebo dreg puff per nostril once a day is administered from 1st Feb.
60mg of fexofenadine orally twice a day can be used as a backup drug.

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

1)The history of Japanese cedar pollinosis for at least one season before study entry.
2)Positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2.
3)Mild / severe nasal symptoms with pollinosis in ARIA
4)Written informed consent is required.

Key exclusion criteria

1)Taking any immunosuppressive drugs or systemic steroid drugs within six months before study entry.
2)Taking any antibiotics within two weeks before study entry.
3)Taking any anti-allergy drugs within two weeks before study entry.
4)Using any anti-allergy nasal drops within two weeks before study entry.
5)Under treatment of buildup phase of specific immunotherapy.
6)Patients with severe deflected nasal septum, sinusitis, or nasal polyps.
7)Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma.
8)Patients with severe cardiac, hepatic, kidney disease.
9)A history of hypersensitivity to fluticasone furoate, loratadine.
10)Pregnant or lactating women and women who may be pregnant.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keisuke Masuyama

Organization

University of Yamanashi

Division name

Department of Otorhinolaryngology, Head & Neck Surgery

Zip code


Address

1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN

TEL

055-273-6769

Email

mkeisuke@yamanshi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomokazu Matsuoka

Organization

University of Yamanashi

Division name

Department of Otorhinolaryngology, Head & Neck Surgery

Zip code


Address

1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN

TEL

055-273-6769

Homepage URL


Email

tmatsu@yamanashi.ac.jp


Sponsor or person

Institute

Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi

Institute

Department

Personal name



Funding Source

Organization

Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi

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

山梨大学 医学部 附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 15 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

No longer recruiting

Date of protocol fixation

2013 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 15 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 01 Month 25 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 15 Day

Last modified on

2016 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name