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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003374
Receipt No. R000004099
Scientific Title Open-labeled, randomized, parallel-group study comparing fluticasone furoate nasal spray and oral loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis
Date of disclosure of the study information 2010/03/24
Last modified on 2016/10/18

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Basic information
Public title Open-labeled, randomized, parallel-group study comparing fluticasone furoate nasal spray and oral loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis
Acronym Randomized study comparing fluticasone furoate and loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis (FLEES study)
Scientific Title Open-labeled, randomized, parallel-group study comparing fluticasone furoate nasal spray and oral loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis
Scientific Title:Acronym Randomized study comparing fluticasone furoate and loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis (FLEES study)
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 effects of fluticasone furoate and loratadine on sleep disorder in 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 Apnea hypopnea index, The Pittsburgh Sleep Quality Index
Key secondary outcomes Total nasal symptom score, Total ocular symptom score, Rhinoconjunctivitis QOL Questionaire score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
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 the beginning of pollinosis symptoms as a first-line drug.
10 mg of loratadine orally once a day can be used as a backup drug.
Interventions/Control_2 Oral loratadine 10 mg once a day is administered from the beginning of pollinosis symptoms as a first-line drug.
Fluticasone furoate nasal spray once a day 110 micro gram can be used as a backup drug.
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
18 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1)A 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)BMI<25
5)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 50

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@yamanashi.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 tmatsuyamanashi@yahoo.co.jp

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

Funding Source
Organization None
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 付属病院

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 24 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
2009 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 24 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004099

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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