Fasenra: An Asthma Study

Part of paid clinical trials in Skokie, Illinois.

Sponsor
Endeavor Health
Study ID
NCT07654842
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Budesonide-albuterol — DRUG
    Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
  • Benralizumab — DRUG
    Participants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 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).

Primary Outcome Measure

Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle [ Time Frame: Weeks 17 through 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor HealthSkokieIllinois60077
Madeline Snedden
847-663-8530
Samantha Gonogora
847-663-8530
Giselle Mosnaim, MD, MS (PRINCIPAL_INVESTIGATOR)
Sarah Gray, MD, MPH (SUB_INVESTIGATOR)
Oscar Salas, MD (SUB_INVESTIGATOR)

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