Fasenra: An Asthma Study (NCT07654842) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Fasenra: An Asthma Study
United States40 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how often people use their anti-inflammatory reliever inhaler during the last dosing cycle of benralizumab (Fasenra) — can you explain what that means for how my asthma would actually be managed day-to-day if I were to participate?
2Since this is a Phase 4 study, benralizumab is already approved, but this trial is still gathering real-world data on how it works — does that change what we know about its safety and benefits compared to what's already available to me as a standard treatment?
3The trial isn't recruiting yet — given where my asthma is right now, would it make more sense to start an existing approved treatment like benralizumab outside of a trial, or would it be worth waiting to see if I might be a candidate for this study when it opens?
4My asthma has been described as severe and eosinophilic — based on my specific test results and history, do you think I'm the type of patient this trial seems to be designed for, and how would you know if benralizumab is even the right drug class for me?
5What would participating in this trial actually require of me in terms of clinic visits, inhaler tracking, or changes to my current medications, and how does that compare to just receiving benralizumab as a standard prescribed treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle
. 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:
. Current enrollment in an asthma-related clinical trial.
. Any known history of adverse reactions to budesonide-albuterol.