The effect of benralizumab on small airways

Ciro0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•Patients eligible for treatment with benralizumab will be aged 18 - 75 years and have a confirmed diagnosis of severe eosinophilic asthma according to ERS/ATS guidelines.
•Pre-bronchodilator FEV1 of ? 80% predicted and history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
•All patients will show persistent blood eosinophilia of >0.3 x 10E9/L despite treatment with high doses of inhaled corticosteroids (>500 ug/day fluticasone equivalent), or >0.15 x 10E9/L despite chronic oral corticosteroid treatment at baseline.
•At least 2 documented asthma exacerbations in the 12 months prior to the date informed consent.
•Females of childbearing potential must have a negative pre-treatment urine pregnancy test.
•Subjects are allowed to use their own inhalation therapy during this study.
•Subjects who are steroid dependent and maintained on an equivalent of =10 mg oral prednisone per day for at least 3 months prior to Visit 1 are eligible, providing the dose of oral steroids remains stable during the run-in period.

•Current smokers or former smokers with a smoking history of =15 pack years. A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1
•Chronic pulmonary disorders other than asthma
•Current malignancy or previous malignancy in remission <12 months
•Prior use of anti IL5 or anti IL5 Receptor monoclonal Antibodies. For patients treated with omalizumab there is a wash out period of 3 month.
•Any other condition that, according to the investigator, may affect the outcome of the study

发起方

Ciro