UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000575 |
|---|---|
| Receipt number | R000000700 |
| Scientific Title | a multicenter, open-labeled, randomized, parallel-group study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis |
| Date of disclosure of the study information | 2007/01/17 |
| Last modified on | 2007/06/21 16:18:36 |
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Basic information
Public title
a multicenter, open-labeled, randomized, parallel-group study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis
Acronym
a randomized study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis (FOREST study)
Scientific Title
a multicenter, open-labeled, randomized, parallel-group study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis
Scientific Title:Acronym
a randomized study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis (FOREST 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 efficacy of fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for 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
Total ocular symptom score (the sum of the severity score of 3 daily ocular symptoms; eye itchiness, tearing, and eye redness ), 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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One fluticasone 50 ug puff per nostril twice a day (total 200 ug/day) is administered from the beginning of pollinosis symptoms to March/31/07 as a first-line drug.
Sixty mg of fexofenadine orally twice a day (total 120mg/day) is started as a backup drug , if daily total nasal symptom score is 4 or more for 4 days or more per week.
Interventions/Control_2
Oral fexofenadine 60 mg twice a day (total 120 mg/day) is administered from the beginning of pollinosis symptoms to March/31/07 as a first-line drug.
One fluticasone 50 ug puff per nostril twice a day (total 200 ug/day) is started as a backup drug, if daily total nasal symptom score is 4 or more for 4 days or more per week.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) a history of Japanese cedar pollinosis for at least 2 seasons before study entry
2) positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2
3) mild nasal symptoms with pollinosis (daily total nasal symptom score <=2) in early pollen season
Key exclusion criteria
1) use of any anti-allergy drugs at the beginning of the study
2) any other nose/paranasal sinus disease, pharyngitis, laryngitis, respiratory tract infection, asthma
3) a history of glaucoma, gastric ulcer, uncontrollable hypertension/diabetes, hepatitis, malignant tumor
4) buildup phase of specific immunotherapy to Japanese cedar pollen
5) a history of nose/paranasal sinus surgery
6) a history of hypersensitivity to fluticasone propionate or fexofenadine hydrochroride
7) pregnancy, potential pregnancy, or lactation
Target sample size
120
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zensei Matsuzaki |
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
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
Kyoto University
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 01 | Month | 17 | 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
| 2006 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 16 | Day |
Last modified on
| 2007 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000700
