Fasenra Demonstrates Durability Over the Full 8-week Treatment Period
Endeavor Health
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.
Description
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 benrali…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. 2. At least 18 years of age at the time of signing the informed consent at Visit 1. 3. Documented asthma diagnosis ≥12 months prior to Visit 1. This may be documented by physician-diagnosis or by documented pharmacy records. 4. 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 mu…
Interventions
- DrugBudesonide-albuterol
Budesonide-albuterol will be used as an anti-inflammatory reliever inhaler for the duration of the study.
- DrugBenralizumab
Participants will continue using benralizumab as prescribed. Benralizumab is not supplied by the study.
Location
- Endeavor HealthSkokie, Illinois