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.
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).
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)
Parallel
ICS-LABA
Combination productICS-LABA inhalation
benralizumab
Combination productBenralizumab. SC injection.
Placebo for Benralizumab
Combination productPlacebo for Benralizumab (aka, "placebo"). SC injection.
Annualized asthma exacerbation rate
To assess asthma exacerbation rate.
Change in Saint George's Respiratory Questionnaire (SGRQ) total score
The SGRQ is a 50-item ePRO instrument developed to measure the health status of participants with airway obstruction disease. The questionnaire is divided into 2 parts: Part 1 consists of 8 items that pertain to the severity of respiratory symptoms in the preceding 4 weeks, and Part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 component scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score ranges from 0 to 100 with 0 indicating the best possible health status and 100 representing the worst possible health status
Change in pre-bronchodilator FEV1
Lung function is assessed by FEV1 which was measured by spirometry. Spirometry will be performed by the Investigator or authorized delegate according to American Thoracic Society /European Respiratory Society guidelines.
Change in Asthma control questionnaire (ACQ) scale score.
The ACQ-6 is a shortened version of the full 7-item ACQ questionnaire, which assesses asthma symptoms (nighttime awakening, symptoms on awakening, activity limitation, shortness of breath, wheezing, SABA use) but omits the FEV1 measurement from the original ACQ-7 assessment. Participants are asked to recall how their asthma has been during the previous week by responding to 6 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The total ACQ-6 score is the mean of the responses. The effect of benralizumab will be evaluated with the change from baseline in ACQ-6 to End of treatment (week 48) and over the treatment period.
Time to first asthma exacerbation
Time to the first occurrence of asthma exacerbation post randomisation.
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