EUCTR2022-000152-11-PT进行中（未招募）1 期
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters - BURA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
- •- Participants who have documented treatment with ICS and LABA for = 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
- •- Participants who have documented peripheral blood eosinophil count = 300 cells/µL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count = 150 cells/µL at V0.
- •- Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
- •- Participants who have pre-bronchodilator FEV1/FVC = 70% at Visit 0 (V0).
- •- Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V0.
- •- Participants who have stable asthma regimen apart from the use of rescue medication including the use of any other asthma medication for at least 3 months prior to V0.
- •- Participants who can perform acceptable and repeatable spirometry.
- •- Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
- •- Persons capable of becoming pregnant, who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control (confirmed by the investigator – and consistent with local regulations regarding the methods of contraception for those participating in clinical studies) from randomization throughout the study duration and within 12 weeks after last dose of IP.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
- •- Participants with acute upper or lower airway infection in the 6 weeks before V0.
- •- Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
- •- Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer. Participants who received Fasenra® any time prior to Visit 0 (V0) will also be excluded.
- •- History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
- •- History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
- •- Participants with current malignancy or history of malignancy.
- •- History of other clinically significant disease or abnormality.
- •- Participants with positive Hepatitis B, C or HIV.
- •- Participants with:
- •Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).
研究者
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