Fasenra: An Asthma Study
Fasenra Demonstrates Durability Over the Full 8-week Treatment Period
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
January 1, 2028
June 17, 2026
June 1, 2026
1.2 years
May 21, 2026
June 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle
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
Secondary Outcomes (3)
Change in anti-inflammatory reliever inhaler use during all benralizumab dosing cycles
Weeks 1 through 24
Number of days per week without anti-inflammatory reliever inhaler use
Weeks 1 through 24
Time to severe asthma exacerbation
Weeks 1 through 24
Study Arms (1)
Open-Label benralizumab + budesonide-albuterol
OTHERParticipants 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).
Interventions
Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
Participants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.
Eligibility Criteria
You may qualify if:
- 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 1.
- Documented asthma diagnosis ≥12 months prior to Visit 1. 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 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).
- 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).
You may not qualify if:
- Current smoker (including tobacco, vaping, and marijuana). Former smokers must have stopped ≥6 months prior to Visit 1.
- 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 1.
- 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)
- Current enrollment in an asthma-related clinical trial.
- Any known history of adverse reactions to budesonide-albuterol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
- AstraZenecacollaborator
Study Sites (1)
Endeavor Health
Skokie, Illinois, 60077, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giselle Mosnaim, MD, MS
Endeavor Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Allergy & Immunology Research
Study Record Dates
First Submitted
May 21, 2026
First Posted
June 17, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
June 17, 2026
Record last verified: 2026-06