UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Keisuke Masuyama
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngology, Head & Neck Surgery
Address	1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL	055-273-6769
Email	mkeisuke@yamanashi.ac.jp

Public contact
Name of contact person	Tomokazu Matsuoka
Organization	University of Yamanashi
Division name	Department of Otorhinolaryngology, Head & Neck Surgery
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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