Fasenra: An Asthma Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndeavor Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Use of systemic corticosteroids for at least 3 consecutive days (or a single depo-injectable dose of corticosteroids)
Trial design
Design model
Single group
Treatments tested in this trial
Budesonide-albuterol
DrugBudesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
Benralizumab
DrugParticipants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Open-Label benralizumab + budesonide-albuterolOther 2 interventions
Trial outcomes
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.
Time frame
Weeks 17 through 24Secondary outcomes
1
Change in anti-inflammatory reliever inhaler use during all benralizumab dosing cycles
Difference between ICS-SABA uses in the first and last two weeks of all 3 benralizumab dosing cycles during the study period.
Time frame
Weeks 1 through 242
Number of days per week without anti-inflammatory reliever inhaler use
Number of days with 0 ICS-SABA uses per week in relation to most recent benralizumab administration.
Time frame
Weeks 1 through 243
Time to severe asthma exacerbation
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.
Time frame
Weeks 1 through 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Endeavor Health
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov
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