RecruitingEosinophilic Asthma

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Eligible age

12–75 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Sponsor: AstraZeneca

You may qualify if…

✓ Written informed consent
✓ Participant must be 12 to 75 years of age
✓ Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
✓ Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
✓ Weight of ≥ 35 kg.
✓ Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
✓ Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
✓ ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.

You may not qualify if…

✕ Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
✕ Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
✕ Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
✕ Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)
✕ Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
✕ History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
✕ Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.