NCT05552508已完成4 期
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 26
- 主要终点
- Change From Baseline in Untrimmed Total Mucus Volume at TLC
研究概览
简要总结
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.
详细描述
This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.
This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications.
Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks.
This study will comprise of:
Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 V
- •Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V
- •Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≤ 70% at Visit 0 (V0).
- •Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V
- •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.
- •Female participants 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 from randomization throughout the study duration and within 12 weeks after last dose of IP.
排除标准
- •Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V
- •Participants with acute upper or lower airway infection in the 6 weeks before V
- •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.
- •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).
结局指标
主要结局
Change From Baseline in Untrimmed Total Mucus Volume at TLC
时间窗: Baseline and Week 13
Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at total lung capacity (TLC) measurements from untrimmed airways was assessed.
次要结局
- Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Air Trapping at FRC(Baseline and Week 13)
- Change From Baseline in Trimmed Distal Airway Wall Volume at TLC(Baseline and Week 13)
- Change From Baseline in Untrimmed Distal Airway Volume at TLC(Baseline and Week 13)
- Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC)(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Lung Volume at TLC(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Lung Volume at FRC(Baseline and Week 13)
- Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1)(At Baseline (Week 0))
- Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1(At Baseline (Week 0))
- Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC)(At Baseline (Week 0))
- Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC(At Baseline (Week 0))
- Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC(At Baseline (Week 0))
- Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC(Baseline and Week 13)
- Number of Participants With Adverse Events (AEs)(From screening (Day -21) to follow-up (up to 1.9 years))
研究者
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