Sequential omalizumab for partial responders to previous biological treatments for severe asthma (OPT Study)

未提供0 个研究点目标入组 90 人开始时间: 2024年7月4日最近更新: 2025年1月21日

试验速览

阶段: 不适用
状态: 进行中（未招募）
入组人数: 90
主要终点: Proportion of patients achieving a partial response at 24 weeks after switching from other biologics to omalizumab treatment

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Patients who have given their written consent to participate in this study before performing any protocol-related steps
•Patients who have been diagnosed with bronchial asthma by a doctor at least 12 months before the date of consent acquisition (Visit 1)
•Patients who are 18 years of age or older at the time of consent, regardless of gender
•Patients who have been treated with high-dose ICS plus two or more types of maintenance therapy such as LABA or LAMA for more than 6 months.
•Patients who have been receiving treatment with biological agents other than omalizumab for more than 6 months until the consent date.
•Patients with the following conditions at the time of obtaining consent due to drugs currently being administered:
•Patients who meet at least one item in Criterion A and at least one item in Criterion B below
•(If at least one of the criteria A and B is satisfied, the eligibility is satisfied even if the test values of criteria A 1-3 and criteria B 1-3 are missing.)
•Criterion A: Items reflecting treatment responsiveness
•1.The frequency of exacerbations of asthma symptoms has decreased by 50% or more compared to when treatment with the currently used biological drug was started (at least 12 months ago).
•No worsening of asthma symptoms is observed during the period of use of the current biological drug (at least 6 months or more). (ACQ-5<1.5)
•Due to current use of the biologic (for at least 6 months), the amount of OCS used as maintenance therapy has decreased by 50% or more since the start of biologic therapy.
•Criterion B: Items reflecting symptoms and instability of respiratory function
•1.%FEV1<80%
•I have asthma symptoms every day.
•Having asthma symptoms at night at least once a week
•Patients who conducted a year-round inhalation antigen test on Visit 1 (or up to Visit 2) and were found to be positive.
•Patients with a total serum IgE level of 30 to 500 IU/mL as determined by blood sampling at Visit 1 (or up to Visit 2)
•Patients whose dosing interval of omalizumab is every 4 weeks according to the dosing schedule calculated from body weight and total IgE level
•Selection criteria 7), 8), and 9) will be checked at the time of Visit 2 to see if they meet the criteria.
•Definition of exacerbation
•Moderate asthma exacerbation
•A condition that requires systemic steroid administration (hereinafter referred to as rescue treatment) for more than 3 days (hereinafter referred to as rescue treatment) at the time of outpatient or emergency department visit (less than 24 hours).
•Severe asthma exacerbation
•Exacerbation of any of the following
•A condition that requires rescue treatment for more than 3 days and requires hospitalization.
•Conditions that require rescue treatment for more than 3 days and emergency department visits (24 hours or more).
•Death from asthma.
•Emergency department visits for more than 24 hours are hospitalization.
•A single dose of depot injection of corticosteroids is considered equivalent to a three-day course of systemic steroid drugs.

排除标准

•Patients receiving intermediate or low doses of ICS
•Patients with high-dose ICS and a biological agent added to only one long-term control drug
•Patients with a history of chronic lung disease (including comorbidities) other than asthma or heart failure
•Women who are pregnant or breastfeeding
•Patients with cancer/malignant tumor undergoing treatment
•Patients who have previously been treated with omalizumab and who have concerns about safety, such as the occurrence of adverse events thought to be caused by omalizumab, or a history of hypersensitivity to the components of this drug.
•Patients who are judged by the research physician to be inappropriate for this study
•Patients whose dosing interval for omalizumab is every 2 weeks according to the dosing schedule calculated from body weight and total IgE level

结局指标

主要结局

Proportion of patients achieving a partial response at 24 weeks after switching from other biologics to omalizumab treatment

时间窗: 24 weeks

The definition of partial response is to satisfy at least one of the following criteria A and 3 items, and at least one item of criteria B and 3 items. **Criterion A: Items reflecting treatment response (assessed at week 0 and week 24.)** 1) The frequency of asthma symptom exacerbations (in the last 1 year) has decreased by more than 50% compared to when the current biologic treatment was started (at least 12 months ago). 2) No worsening of asthma symptoms is observed during the current period of use of biologics (at least 6 months or more). (ACQ-5<1.5) 3) Current use of biologics (at least 6 months or more) has reduced the use of OCS as maintenance therapy by more than 50% since the start of biologic therapy. **Criterion B: Items reflecting symptoms and respiratory instability (assessed at 24 weeks)** 1) %FEV1<80% 2) You have asthma symptoms every day. 3) Asthma symptoms at night at least once a week

次要结局

Percentage of patients who achieved clinical remission after 24 weeks of treatment with omalizumab(24 weeks)

研究者

发起方

未提供

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