Unique ID issued by UMIN | UMIN000005986 |
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Receipt number | R000005256 |
Scientific Title | Randomized, double-blind, placebo-controlled trial of efficacy of mometasone furoate nasal spray in the initial treatment of Japanese cedar pollinosis |
Date of disclosure of the study information | 2011/07/15 |
Last modified on | 2013/02/11 14:36:50 |
Randomized, double-blind, placebo-controlled trial of efficacy of mometasone furoate nasal spray in the initial treatment of Japanese cedar pollinosis
Efficacy of mometasone in the initial treatment of Japanese cedar pollinosis
Randomized, double-blind, placebo-controlled trial of efficacy of mometasone furoate nasal spray in the initial treatment of Japanese cedar pollinosis
Efficacy of mometasone in the initial treatment of Japanese cedar pollinosis
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
Efficacy of treatment
Efficacy
Nasal symptom score
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
In February 1st, 2010, patients begin to receive mometasone (200 ug per day). This treatment was continued until the end of April for 12 weeks.
In February 1st, 2010, patients begin to receive placebo. This treatment was continued until the end of April for 12 weeks.
16 | years-old | <= |
65 | years-old | > |
Male and Female
(a) at least two year history of JCCP; (b) sensitization to Japanese cedar pollen assessed by skin prick test; (c) ability to fill in the diary cards accurately
(a) concomitant sinonasal disease affecting the outcomes of this trial (e.g. nasal polyps, rhinosinusitis, nasal septum deviation); (b) concomitant treatment-requiring allergic rhinitis caused by allergens other than Japanese cedar/cypress pollen; (c) rhinitis medicamentosa and non-infectious, non-allergic rhinitis; (d) cedar pollen-specific immunotherapy; (e) sinonasal surgery including laser vaporization of inferior turbinates within 1 year; (f) medication with anti-allergic drugs including antihistamines, chromons, glucocorticoids and decongentants within 2 weeks; (g) hypersensitivity to MFNS; (h) systemic infection including mycosis; (i) pregnancy and breastfeeding
50
1st name | |
Middle name | |
Last name | Mitsuhiro Okano |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Otolaryngology-Head & Neck Surgery
2-5-1 Shikatacho, Okayama
1st name | |
Middle name | |
Last name |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Otolaryngology-Head & Neck Surgery
2-5-1 Shikatacho, Okayama
086-235-7307
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Self Funding
Self funding
Japan
NO
2011 | Year | 07 | Month | 15 | Day |
Published
Weekly TNSS, TOSS, and TSS were lower in the EIT group as compared with the controls, and differences were significant in March when the POT groups did receive the active treatment. Average TSS in EIT group (score 2.3) during 12 weeks was significantly lower than not only placebo (score 5.0, P<0.01) but also POT group (score 3.9, P=0.03). The proportion of MSD was also significantly higher in EIT group as compared with placebo and POT group.
Completed
2009 | Year | 11 | Month | 30 | Day |
2009 | Year | 12 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 07 | Month | 15 | Day |
2013 | Year | 02 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005256
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