Do you suffer from uncontrolled Eosinophilic Asthma?
This clinical research study is looking at the safety and effectiveness of a medication for people with severe asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath.
This is a randomized, active-controlled study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).
Would you like to contribute to medical research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all Canadians with asthma. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Provide written informed consent
- Are 12 to 75 years of age
- Have a 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.
- Have 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).
- Have a weight of ≥ 35 kg.
- Have pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
- Have documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
- Have a ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
- Have evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
- Have peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
- Have at least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary
You may not qualify to participate if you:
- Have any 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.
- Have had an 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
- Have any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
- Have clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator’s discretion)
- Have a history of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
- Are a current smoker or former smoker with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
