Unique ID issued by UMIN | UMIN000004930 |
---|---|
Receipt number | R000005868 |
Scientific Title | Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study |
Date of disclosure of the study information | 2011/01/22 |
Last modified on | 2011/01/22 14:34:01 |
Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Comparison of Fluticasone Furoate and Fexofenadine hydrochloride as initial treatment for Japanese cedar pollinosis: single-center,randomized,parallel-group study
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
This study is a prospective single-center,randomized,parallel-group study comparing the effects of initial treatment with Fluticasone Furoate and Fexofenadine hydrochloride
Efficacy
Confirmatory
Pragmatic
Total nasal symptom score
Total ocular symptom score,
Japan Rhinoconjunctivitis QOL Questionaire
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Fluticasone furoate puff per nostril once a day 110µg is administered as initial treatment for Japanese cedar pollinosis.
60mg of Fexofenadine orally twice a day can be used as a backup drug.
60mg of Fexofenadine orally twice a day is administered as initial treatment for Japanese cedar pollinosis.
Fluticasone furoate puff per nostril once a day 110µg can be used as a backup drug.
15 | years-old | <= |
Not applicable |
Male and Female
Patients diagnosed with Japanese cedar pollinosis and who desire initial therapy and meet following requirements
1)A history of Japanese cedar pollinosis for at least one season before study entry
2)patient can write down the pollinosis-dairy of this study appropriately from the doctor's viewpoint
3)patient can keep the rule of this study and doctor's direction from the doctor's viewpoint
4)obtain informed consent before registration to this study
5)Patient aged 15 years and above when doctors obtain informed consent
1)patient experienced adverse effect by components of study drug
2)patients who is pregnant or suspected of pregnancy , wish to get pregnant , nursing mom
3)inappropriate patient for this study from the doctor's viewpoint
60
1st name | |
Middle name | |
Last name | Mikiya Asako |
Kansai Medical University Hirakata Hospital
Otolaryngology Head and neck surgery
2-3-1shinmachi,hirakata,osaka
072-804-0101
1st name | |
Middle name | |
Last name | Mikiya Asako |
Kansai Medical University Hirakata Hospital
Otolaryngology Head and neck surgery
2-3-1shinmachi,hirakata,osaka
072-804-0101
Kansai Medical University
none
Self funding
NO
2011 | Year | 01 | Month | 22 | Day |
Unpublished
Preinitiation
2010 | Year | 12 | Month | 24 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 01 | Month | 22 | Day |
2011 | Year | 01 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005868
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |