A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
研究概览
简要总结
This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.
详细描述
This is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of Tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting β2 agonist and oral corticosteroids with or without additional asthma controller medications.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tezepelumab
Tezepelumab subcutaneous injection
干预措施: Tezepelumab (Biological)
结局指标
主要结局
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
时间窗: Week 28 and Week 52
The proportion (expressed as a percentage) of participants who discontinued OCS without loss of asthma control is presented. Loss of asthma control was defined as asthma worsening or exacerbation. Asthma worsening was defined by an increase of Asthma Control Questionnaire 6 (ACQ-6) score ≥0.5 from baseline. Asthma exacerbation was defined by worsening of asthma symptoms that led to temporary bolus/burst of systemic corticosteroids (SCS; or a temporary increase in stable OCS background dose) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids being considered equivalent to a 3-day bolus/burst of SCS), and/or an emergency room (ER) or urgent care visit requiring SCS, and/or inpatient hospitalisation, both due to asthma.
Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52
时间窗: Week 28 and Week 52
The proportion (expressed as a percentage) of the participants who reduced daily prescribed maintenance OCS dose to ≤5 mg/day without loss of asthma control at Week 28 and Week 52 is presented.
次要结局
- Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52(Week 28 and Week 52)
- Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks(Week 28 and Week 52)
- Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks(Week 28 and Week 52)
- Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks(Week 28 and Week 52)
- Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks(Week 28 and Week 52)
- Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks(Week 28 and Week 52)
- Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52(Week 28 and Week 52)
- Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52(Week 28 and Week 52)
- Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52(Week 28 and Week 52)
- Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52(Week 28 and Week 52)
- Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52(Week 28 and Week 52)
- Change From Baseline in ACQ-6 at Week 28 and Week 52(Week 28 and Week 52)
- Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52(Week 28 and Week 52)
- Change From Baseline in SGRQ Total Score at Week 28 and Week 52(Week 28 and Week 52)