Unique ID issued by UMIN | UMIN000001282 |
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Receipt number | R000001561 |
Scientific Title | Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber |
Date of disclosure of the study information | 2008/08/04 |
Last modified on | 2009/11/02 13:12:58 |
Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber
TOPIC Study ( Trial of OHIO Chamber - Pranlukast Inhibitory Effect for Cedar Exposure -)
Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber
TOPIC Study ( Trial of OHIO Chamber - Pranlukast Inhibitory Effect for Cedar Exposure -)
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
The study objective is to compare the efficacy of Pranlukast and placebo on the subjects with the artificially induced nasal symptoms exposed to a definite concentration of Japanese cedar pollen in the OHIO Chamber.
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
nose and eye symptoms
the number of sneezing, the amount of nasal secretion, the manifestation time of nasal symptoms, nasal airway resistance, respiratory function and performance test( D-CAT )
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Two pranlukast capsules are orally administered after the meal 4 times ( 2 times before the exposure and 2 times after the exposure ). The study consists of 2 times exposure in OHIO Chamber at one week intervals.
Two placebo capsules are orally administered after the meal 4 times ( 2 times before the exposure and 2 times after the exposure ). The study consists of 2 times exposure in OHIO Chamber at one week intervals.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Subjects must have at least a 2-year history of allergic symptoms during the Japanese cedar pollen season, such as sneezing, nasal discharge and nasal obstruction.
2) Subjects must have had blood tests within a 3 years showing positive CAP-RAST scores ( between 2 and 6 ) for Japanese cedar pollen.
3) Subjects must be appropriate to this study by the judgment of doctor.
4) Informed consent must be obtained from the subjects prior to study entry.
1) Subjects with a polyp or deformity of the nose.
2) Subjects who used steroid drugs for injection within 6 months before the start of this study.
3) Subjects with systemic diseases ( asthma or tuberculosis ).
4) Subjects with build-up phase of immunotherapy to Japanese cedar pollen.
5) Subjects with pregnancy, lactation or potential pregnancy.
6) Subjects who are inappropriate to this study by the judgment of doctor.
36
1st name | |
Middle name | |
Last name | Kimihiro Okubo |
Nippon Medical School
Department of Otolaryngology
1-1-5 Sendagi, Bunkyo-ku, Tokyo
03-3822-2131
1st name | |
Middle name | |
Last name | Minoru Gotoh |
Nippon Medical School Chiba Hokusoh Hospital
Department of Otolaryngology
1715 kamakari inbamura inbagun
0476-99-1111
TOPIC Study (Trial of OHIO Chamber-Pranlukast Inhibitory Effect for Cedar Exposure-)
Public Health Research Foundation
Non profit foundation
Japan
NO
2008 | Year | 08 | Month | 04 | Day |
Unpublished
Completed
2008 | Year | 06 | Month | 19 | Day |
2008 | Year | 07 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 07 | Month | 31 | Day |
2009 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001561
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