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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012861
Receipt No. 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

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

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
URL(English) https://upload.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


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