Unique ID issued by UMIN | UMIN000018619 |
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Receipt number | R000021546 |
Scientific Title | Research on markers for omalizumab therapy in asthma |
Date of disclosure of the study information | 2015/08/11 |
Last modified on | 2022/06/01 15:57:20 |
Research on markers for omalizumab therapy in asthma
Research on markers for omalizumab therapy in asthma
Research on markers for omalizumab therapy in asthma
Research on markers for omalizumab therapy in asthma
Japan |
asthma
Medicine in general | Pneumology | Clinical immunology |
Others
NO
To find markers for Omalizumab therapy.
Others
To find markers for Omalizumab therapy.
Relationship between clinical outcomes and biomarkers.
Observational
20 | years-old | <= |
100 | years-old | >= |
Male and Female
Patients planned to use omalizumab.
Patients without researcher's assent.
20
1st name | Maho |
Middle name | |
Last name | Suzukawa |
National Hospital Organization, Tokyo National Hospital
Clinical Research Center
204-8585
3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585
0424912111
fueta-tky@umin.ac.jp
1st name | Kenichi |
Middle name | |
Last name | Konno |
National Hospital Organization Tokyo National Hospital
Clinical Research Center
204-8585
3-1-1 Takeoka, Kiyose-City, Tokyo 204-8585
0424912111
fueta-tky@umin.ac.jp
National Hospital Organization, Tokyo National Hospital
Clinical Research Center
National Hospital Organization
Other
National Hospital Organization Tokyo National Hospital
3-1-1 Takeoka, Kiyose, Tokyo, Japan
0424912111
fueta-tky@umin.ac.jp
YES
184
Ethics Committee of Tokyo National Hospital
2015 | Year | 08 | Month | 11 | Day |
https://www.resmedjournal.com/article/S0954-6111(17)30413-4/fulltext
Published
https://www.resmedjournal.com/article/S0954-6111(17)30413-4/fulltext
31
GETE assessment showed 19 responders (61.3%) and 12 non-responders (38.7%). Responders showed significantly higher levels of CXCL10 and IL-12 at baseline compared to non-responders . ROC curves to distinguish responders from non-responders using the baseline serum CXCL10 level showed a good AUC of 0.83. At 32 weeks of omalizumab therapy, serum CXCL10 tended to be increased and serum IL-12 tended to be decreased . On the other hand, serum IL-5 and PDGF were significantly decreased .
2022 | Year | 06 | Month | 01 | Day |
Thirty-one patients with severe, persistent asthma were enrolled in this study and administered omalizumab for at least 1 year.
Response to omalizumab was assessed based on the physician's global evaluation of treatment effectiveness (GETE) at 48 weeks of treatment. Blood samples were collected at baseline and 16 and 32 weeks after starting omalizumab and measured for 30 cytokines by Luminex 200 and ELISA. Exhaled nitric oxide (FeNO) levels, peripheral blood eosinophil counts, pre-bronchodilator pulmonary functions and Asthma Quality of Life Questionnaire scores were determined at baseline and 16, 32 and 48 weeks after starting omalizumab. The numbers of clinically significant asthma exacerbations in the previous year and during 48 weeks of treatment with omalizumab were assessed.
N.A.
Response to omalizumab was assessed based on the physician's global evaluation of treatment effectiveness (GETE) at 48 weeks of treatment.
FeNO levels, eosinophil counts, pulmonary functions, AQLQ, serum cytokine levels, and asthma exacerbations were compared at baseline and 16, 32 and 48 weeks after starting omalizumab.
Completed
2013 | Year | 06 | Month | 26 | Day |
2013 | Year | 06 | Month | 26 | Day |
2013 | Year | 06 | Month | 26 | Day |
2015 | Year | 06 | Month | 25 | Day |
2015 | Year | 12 | Month | 14 | Day |
Case control observational study
All patients who met criteria for this study will be enrolled.
Data collection: pulmonary function tests, blood eosinophils, serum immunoglobulins and cytokines.
2015 | Year | 08 | Month | 10 | Day |
2022 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021546
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