Fasenra Demonstrates Durability Over the Full 8-week Treatment Period
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
- •At least 18 years of age at the time of signing the informed consent at Visit
- •Documented asthma diagnosis ≥12 months prior to Visit
- •This may be documented by physician-diagnosis or by documented pharmacy records.
- •Treated with a daily ICS-containing maintenance inhaler for asthma at a stable dose for ≥3 months prior to Visit
- •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).
- •Prescribed a SABA-containing reliever inhaler, AND willing to use study-provided ICS-SABA reliever with EMM provided by the study.
- •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).
排除标准
- •Current smoker (including tobacco, vaping, and marijuana). Former smokers must have stopped ≥6 months prior to Visit
- •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.
- •History of use of any biologic therapy for asthma (other than benralizumab) within 5 half-lives or 5 months, whichever is longer, before Visit
- •A severe asthma exacerbation within 4 weeks of Visit
- •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)
- •Current enrollment in an asthma-related clinical trial.
- •Any known history of adverse reactions to budesonide-albuterol.
研究组 & 干预措施
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).
干预措施: Benralizumab (Drug)
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).
干预措施: Budesonide-albuterol (Drug)
研究者
Giselle Mosnaim
Director of Allergy & Immunology Research
Endeavor Health