此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Fasenra: An Asthma Study

2026年9月11日 更新者：Giselle Mosnaim、Endeavor Health

Fasenra Demonstrates Durability Over the Full 8-week Treatment Period

The goal of this observational study is to learn more about the effectiveness of benralizumab (Fasenra, 30 mg every 8 weeks) in maintaining asthma control in people with severe eosinophilic asthma.

Participants will have electronic medication monitors fitted to their usual maintenance inhaler, as well as a study-provided anti-inflammatory rescue inhaler, albuterol-budesonide (AirSupra). These monitors will track when each inhaler is used. Participants will also upload time-stamped photos of their benralizumab administration to their electronic medical records.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

This will be a 26-week prospective, single arm study. At Visit 1 (in-person visit at day -14), scheduled two weeks before they are due for their next dose of benralizumab, participants will provide informed consent, demographics information, and have Adherium electronic medication monitors (EMM) fitted onto their inhaled corticosteroid (ICS)-containing maintenance and inhaled corticosteroid-short-acting β2-agonist (ICS-SABA) reliever medications . The patient-facing research assistant (pRA) will ask participants for the dates they plan to administer each of the following three doses of benralizumab, at 8-week intervals (±7 days), and schedule video visits two, three, and four on those dates to confirm the patient received the benralizumab. If the patient cannot complete a video visit for directly observed therapy of benralizumab administration, they can also upload a time and date stamped photo of themselves administering the benralizumab to their EMR via the MyChart Patient Portal within 48 hours of administration. Participants will continue usual care with their asthma health care professional, and the study team will collect any interval Asthma Control Test (ACT), spirometry (e.g., forced exhalation volume in the first second (FEV1), forced vital capacity (FVC), and FEV1/FVC), and fractional exhaled nitric oxide (FENO) measurements, as well as oral corticosteroid (OCS) use (both OCS bursts and changes in daily OCS dose, as applicable), immediate care visits, emergency department (ED) visits, and hospitalizations for asthma.

The pRA will perform all of their tasks under the supervision of the study investigators (an allergist and immunologist and a pulmonologist). At visit one, the pRA will teach each participant how to: attach the Adherium EMM to their ICS-SABA reliever and ICS-containing maintenance medications; download the Adherium asthma App to their smartphone; pair the EMM with their smartphone App; and view their ICS adherence and ICS-SABA usage, as well as inhalation quality, on the App. Each month, under the supervision of the study investigators, the pRA will review the remote therapeutic monitoring data for each participant's ICS-SABA reliever and ICS-containing maintenance medications and document the results of this review in the patient's chart.

Data collected during the study include:

  • Maintenance inhaler use
  • Rescue inhaler use
  • Dates of benralizumab administration
  • Dates of severe asthma exacerbations
  • Oral corticosteroid use
  • Healthcare visits for asthma
  • AIRQ scores
  • Results from standard of care assessments, including ACT scores, lung function values, FeNO, and absolute eosinophil counts
  • Demographic information, including age, gender, race, ethnicity, and insurance

研究类型

介入性

注册 (估计的)

40

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Illinois
      • Skokie、Illinois、美国、60077
        • Endeavor Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
  2. At least 18 years of age at the time of signing the informed consent at Visit 1.
  3. Documented asthma diagnosis ≥12 months prior to Visit 1. This may be documented by physician-diagnosis or by documented pharmacy records.
  4. Treated with a daily ICS-containing maintenance inhaler for asthma at a stable dose for ≥3 months prior to Visit 1. This inhaler may contain ICS alone, or in combination with a LABA or LABA-LAMA. The prescribed inhaler must be compatible with a study-provided EMM (see Appendix A).
  5. Prescribed a SABA-containing reliever inhaler, AND willing to use study-provided ICS-SABA reliever with EMM provided by the study.
  6. Prescribed benralizumab for severe eosinophilic asthma for ≥6 months AND has had ≥4 benralizumab doses (3 loading doses + at least 1 8-week dosing interval).

Exclusion Criteria:

  1. Current smoker (including tobacco, vaping, and marijuana). Former smokers must have stopped ≥6 months prior to Visit 1.
  2. Has a known, preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, or any other system abnormalities that are uncontrolled with standard treatment, which, in the investigator's opinion, would compromise the participant's safety, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence.
  3. History of use of any biologic therapy for asthma (other than benralizumab) within 5 half-lives or 5 months, whichever is longer, before Visit 1.

  4. A severe asthma exacerbation within 4 weeks of Visit 1. For this study, a severe asthma exacerbation is defined as an episode of worsening asthma symptoms that result in at least one of the following:

    • Use of systemic corticosteroids for at least 3 consecutive days (or a single depo-injectable dose of corticosteroids)
    • An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma
    • An emergency department visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care) due to asthma that required systemic corticosteroids (as per above)
  5. Current enrollment in an asthma-related clinical trial.
  6. Any known history of adverse reactions to budesonide-albuterol.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Open-Label benralizumab + budesonide-albuterol
Participants will continue their usual treatment with benralizumab (300mg every 8 weeks) and inhaled corticosteroid-containing maintenance inhaler (as prescribed by their usual clinician). During the study, participants will be asked to switch their usual reliever inhaler to study-provided budesonide-albuterol (also known as AirSupra).
药品：Budesonide-albuterol
Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
其他名称：
  • AirSupra
药品：Benralizumab
Participants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.
其他名称：
  • 法森拉

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle
大体时间：Weeks 17 through 24
Difference between ICS-SABA uses in the first and last two weeks of the 3rd of 3 benralizumab dosing cycles during the study period.
Weeks 17 through 24

次要结果测量

结果测量
措施说明
大体时间
Change in anti-inflammatory reliever inhaler use during all benralizumab dosing cycles
大体时间：Weeks 1 through 24
Difference between ICS-SABA uses in the first and last two weeks of all 3 benralizumab dosing cycles during the study period.
Weeks 1 through 24
Number of days per week without anti-inflammatory reliever inhaler use
大体时间：Weeks 1 through 24
Number of days with 0 ICS-SABA uses per week in relation to most recent benralizumab administration.
Weeks 1 through 24
Time to severe asthma exacerbation
大体时间：Weeks 1 through 24
Time to first severe asthma exacerbation requiring treatment with oral corticosteroids for at least 3 days, urgent care or emergency department visit, hospitalization, or death, in relation to most recent benralizumab administration.
Weeks 1 through 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Endeavor Health

合作者

AstraZeneca

调查人员

  • 首席研究员：Giselle Mosnaim, MD, MS、Endeavor Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • P2025-0057
  • ESR-24-22698 (其他赠款/资助编号：AstraZeneca)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅