UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003374 |
|---|---|
| Receipt number | 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 00:12:54 |
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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
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
tmatsuyamanashi@yahoo.co.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004099
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| Registered date | File name |
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