Unique ID issued by UMIN | UMIN000018777 |
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Receipt number | R000021562 |
Scientific Title | A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD) |
Date of disclosure of the study information | 2015/08/24 |
Last modified on | 2019/08/26 16:43:42 |
A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD)
The efficacy of omalizumab in AERD
A randomized, double-blind, placebo-controlled, crossover study of the efficacy of omalizumab in patients with aspirin-exacerbated respiratory disease (AERD)
The efficacy of omalizumab in AERD
Japan |
Aspirin exacerbated respiratory disease (AERD)
Pneumology | Clinical immunology |
Others
NO
To evaluate the efficacy of omalizumab in patients with AERD
Safety,Efficacy
Change in urinary concentration of leukotriene E4
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Period 1: Patients were treated with omalizumab for 3 months, followed by a washout interval of at least 18 weeks. Period 2: Patients were treated with placebo (saline) for 3 months.
Period 1: Patients were treated with placebo (saline) for 3 months, followed by a washout interval of at least 18 weeks. Period 2: Patients were treated with omalizumab for 3 months.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Patients diagnosed with AERD by a systemic aspirin provocation test within the last two years
2) At least one positive result in either a skin test or a serum-specific immunoglobulin E test for common environmental allergens
3) No previous treatment with omalizumab
4) Able to provide written, signed and dated informed consent
1) Previous treatment with omalizumab
2) Unable to provide written, signed and dated informed consent
3) Patients considered at risk of sinusitis and/or nasal polyp surgery during the study period
4) Patients with comorbidities (renal, hepatic, heart, mental, and malignancy) requiring treatment
5) Pregnancy, breast-feeding, or potential pregnancy
6) Patients considered unsuitable by the attending physician
16
1st name | Masami |
Middle name | |
Last name | Taniguchi |
Sagamihara National Hospital
Clinical Research Center for Allergy and Rheumatology
2520392
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
042-742-8311
taniguchi.masami.ne@mail.hosp.go.jp
1st name | Hiroaki |
Middle name | |
Last name | Hayashi |
Sagamihara National Hospital
Clinical Research Center for Allergy and Rheumatology
2520392
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
042-742-8311
hayashi.hiroaki.kr@mail.hosp.go.jp
Sagamihara National Hospital
Labour Sciences Research Grant
Japanese Governmental office
Ethics Committee of the Organization Sagamihara National Hospital
18-1 Sakuradai Minamiku Sagamihara Kanagawa
042-742-8311
taniguchi.masami.ne@mail.hosp.go.jp
NO
国立病院機構相模原病院(神奈川県)
2015 | Year | 08 | Month | 24 | Day |
Unpublished
16
No longer recruiting
2015 | Year | 08 | Month | 23 | Day |
2014 | Year | 03 | Month | 18 | Day |
2015 | Year | 08 | Month | 24 | Day |
2017 | Year | 08 | Month | 31 | Day |
2015 | Year | 08 | Month | 23 | Day |
2019 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021562
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