Unique ID issued by UMIN | UMIN000030466 |
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Receipt number | R000034785 |
Scientific Title | Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma. |
Date of disclosure of the study information | 2017/12/19 |
Last modified on | 2021/07/31 06:54:13 |
Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers
Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers
Japan |
Asthma
Pneumology | Clinical immunology |
Others
NO
Anti-IL-5 antibody (Ab) has been approved for molecular targeted therapy for asthma. Previous studies consistently showed that anti-IL-5 Ab suppressed the frequency of exacerbation and blood eosinophil count was identified as an important marker for prediction of efficacy. Although, asthma symptom or pulmonary function was not consistently improved by treatment and prediction markers for those index have not been established yet.
The aim of this study is to establish prediction marker for improvement in symptom or pulmonary function. To do this, we analyze the relationship between potential biomarkers other than eosinophils and improvement in symptom or pulmonary function.
In addition, we will also analyze, 1) the efficacy for chronic rhinosinusitis with nasal polyps, 2) the efficacy for reversibility negative patients, who was excluded in previous clinical trials, and 3) precise time course of various clinical index and biomarkers.
Efficacy
Exploratory
Others
The relationship between the levels of candidate biomarkers and improvement in symptom after 32 w treatment.
1) Divide patients into two groups based on median value of pre-dose biomarkers and compare the effect on ACQ-5 score, exacerbation, and FEV1.
2) Relationship between early change (4 to 12 weeks after first injection) in clinical index and final improvement in ACQ-5 score or exacerbation after 32 weeks.
3) Precise time course of various biomarkers.
4) Effect on rhinosinusitis, atopic dermatitis, and otitis media.
5) Comparison of effect between reversibility positive and negative patients, or, patient with smoking history >= and < 10 pack year.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
mepolizumab
18 | years-old | <= |
Not applicable |
Male and Female
1. Treated by >= 400 microg/day of inhaled corticosteroids (fluticasone equivalent) with one or more controllers (LABA, LTRA, or theophylline) for more than 3 months
2. Blood eosinophil counts >= 300/microl in previous 12 month or >= 150/microl at first injection
3. Exacerbation history (>=1) in previous 12 month
4. ACQ 5 score >= 0.75
1. Complicated by pulmonary disease other than asthma
2. Complicated by malignant diseases
3. Diagnosed as hypereosinophilc syndrome or eosinophilic granulomatosis with polyangiitis
4. Administrated omalizumab in previous 30 days
70
1st name | Hiroyuki |
Middle name | |
Last name | Nagase |
Teikyo University School of Medicine
Department of Medicine
1738605
1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan
81-3-3964-8351
nagaseh@med.teikyo-u.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Nagase |
Teikyo University School of Medicine
Department of Medicine
1736605
1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan
81-3-3964-8351
nagaseh@med.teikyo-u.ac.jp
Teikyo University School of Medicine
None
Self funding
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan
03-3964-7256
turb-office@teikyo-u.ac.jp
NO
NTT東日本関東病院 (東京都)、慶應義塾大学病院 (東京都)、順天堂大学医学部付属順天堂江東高齢者医療センター (東京都)、昭和大学病院 (東京都)、帝京大学医学部附属病院 (東京都)、東京女子医科大学病院 (東京都)、日本大学医学部附属板橋病院 (東京都)
2017 | Year | 12 | Month | 19 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034785
Published
https://apallergy.org/DOIx.php?id=10.5415/apallergy.2021.11.e31
20
The serum galectin-10 and ECP significantly decreased 4 weeks after mepolizumab initiation. In contrast, basophil count, FeNO, and the serum total IgE level were unchanged. ACQ-5, AHQ-33, and Lund-Mackay scores also significantly improved . Both high ECP and eosinophil count related to better response in FEV1 and measurable ECP level at 4 weeks after administration of mepolizumab related to the further improvement in FEV1 toward week 32.
2021 | Year | 07 | Month | 31 | Day |
2021 | Year | 07 | Month | 10 | Day |
We included patients with a score of at least 0.75 in ACQ5 during treatment comprising at least 400 microg of fluticasone propionate or the equivalent by inhalation per day and at least 3 months of treatment with an additional controller; those who experienced at least one occurrence of asthma exacerbation that required more than 3 days of systemic corticosteroids, Emergency Department visit, or an admission in the previous year; and blood eosinophil count of at least 150 cells per microL at screening or at least 300 cells per microL at some time during the previous year. Patients with past smoking history were included, and presence of FEV1 reversibility was not necessary.
Mepolizumab was administered every 4 weeks for 32 weeks and the levels of various biomarkers were serially analyzed.
None
At each visit, patients recorded scores of ACQ-5, Asthma Control Test (ACT), and Asthma Health Questionnaire (AHQ)-33 [8], to estimate their quality of life (QoL) and underwent hematologic tests. Pulmonary function testing and measurement of fractional exhaled nitric oxide (FeNO) by NIOX VERO (Circassia AB, Uppsala, Sweden) were performed before starting mepolizumab (week 0) and after 4, 12, and 32 weeks. Airway reversibility was defined as positive when FEV1 increase 200 mL and 12% after inhalation of bronchodilator. Computed tomography (CT) scans of paranasal sinuses were evaluated prior to the first injection of mepolizumab and at 12 and 32 weeks.
Completed
2017 | Year | 04 | Month | 28 | Day |
2017 | Year | 04 | Month | 28 | Day |
2017 | Year | 04 | Month | 29 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 19 | Day |
2021 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034785
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