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Fasenra: An Asthma Study

2026년 6월 12일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

40

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Illinois
      • Skokie, Illinois, 미국, 60077

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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).
의약품: Budesonide-albuterol
Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
다른 이름들:
  • AirSupra
의약품: Benralizumab
Participants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.
다른 이름들:
  • 파센라

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in anti-inflammatory reliever inhaler use during all benralizumab dosing cycles
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Endeavor Health

협력자

AstraZeneca

수사관

  • 수석 연구원: Giselle Mosnaim, MD, MS, Endeavor Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P2025-0057
  • ESR-24-22698 (기타 보조금/기금 번호: AstraZeneca)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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