Fasenra: An Asthma Study
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Skokie, Illinois, Forente stater, 60077
- Endeavor Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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).
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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).
|
Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
Andre navn:
Participants will continue using benralizumab as prescribed.
Benralizumab is not supplied by the study.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in anti-inflammatory reliever inhaler use during all benralizumab dosing cycles
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Giselle Mosnaim, MD, MS, Endeavor Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Sykdommer i luftveiene
- Lungesykdommer
- Bronkiale sykdommer
- Lungesykdommer, obstruktiv
- Respiratorisk overfølsomhet
- Overfølsomhet, Umiddelbar
- Overfølsomhet
- Hypereosinofilt syndrom
- Eosinofili
- Leukocyttforstyrrelser
- Hematologiske sykdommer
- Hemic og lymfatiske sykdommer
- Astma
- Lungeeosinofili
- Benralizumab
Andre studie-ID-numre
- P2025-0057
- ESR-24-22698 (Annet stipend/finansieringsnummer: AstraZeneca)
Plan for individuelle deltakerdata (IPD)
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