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临床试验/NCT05329194
NCT05329194已完成4 期

A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)

AstraZeneca38 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2022年4月29日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
AstraZeneca
入组人数
286
试验地点
38
主要终点
Annualized Asthma Exacerbation Rate (AAER)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.

详细描述

This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults and adolescent participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ICS), with additional controller(s) for at least 12 months with documented history of at least 2 asthma exacerbations during the year prior to enrolment. The total duration of the study for each participant will be approximately 56 weeks. Approximately 400 participants will be enrolled. Participants will receive tezepelumab via subcutaneous injection at the study site, over a 48-week treatment period. The study also includes a post-dosing follow-up period from Weeks 48 to 52.

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
12 Years 至 130 Years（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
  • •Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
  • •Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment.
  • •Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
  • •Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
  • •Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
  • •Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
  • •Provision of signed and dated written informed consent form.

排除标准

  • •Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
  • •Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
  • •Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment.
  • •Participation in an interventional clinical trial for asthma within 12 months prior to enrollment.
  • •Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

研究组 & 干预措施

Tezepelumab

Experimental

Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.

干预措施: Tezepelumab (Drug)

结局指标

主要结局

Annualized Asthma Exacerbation Rate (AAER)

时间窗: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Asthma exacerbations were defined by worsening of asthma symptoms that leads to temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days, or an emergency department (ED) or urgent care visit due to asthma that required systemic corticosteroid (SCS), and/or inpatient hospitalization (≥24 hours) due to asthma. The AAER was based on exacerbations reported by the investigator over 52 weeks. The exacerbation rate was compared between the 12-month period before \[baseline period (BP)\] and the 12-month period after initiation of tezepelumab \[up to study Week 52 (Visit 15) = study period (SP)\].

次要结局

  • Number of Participants With Asthma Exacerbations(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number of Participants Who Completed the 52 -Week Study Period With Any Reduction in Total Number of Asthma Exacerbations(From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52))
  • Cumulative Asthma Exacerbation Days(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Time to First Asthma Exacerbation(Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months))
  • Rate of Asthma Exacerbations Associated With Hospitalizations(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Rate of Asthma Exacerbations Associated With Emergency Department /Urgent Care (ED/UC) Visits(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number of Participants With Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Cumulative Asthma Exacerbation Days Associated With Hospitalizations or ED/UC Visits(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)(Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Change From Baseline in Pre-bronchodilator FEV1(Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months))
  • Number of Pre-BD FEV1 Responders(Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Asthma Control Questionnaire (ACQ-6)(Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Asthma Impairment and Risk Questionnaire (AIRQ)(Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • St. George's Respiratory Questionnaire (SGRQ)(Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Change From Baseline in ACQ-6 Score(Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months))
  • Change From Baseline in AIRQ Score(Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months))
  • Change From Baseline in SGRQ Score(Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months))
  • Number of ACQ-6 Responders(Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Number of AIRQ Responders(Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Number of SGRQ Responders(Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months))
  • Number of Participants Who Require Any Systemic Corticosteroid (SCS) Use(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Cumulative Annualized SCS Dose(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number of Participants Who Require Longer-term (>30 Consecutive Days) SCS Use(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number and Type of Asthma-related Healthcare Resource Utilization (HRU)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Duration of Asthma-related Hospitalizations(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • AAER for Asthma Exacerbations (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number of Participants With Asthma Exacerbations (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number of Participants Who Completed the 52-week Study With Any Reduction in Total Number of Asthma Exacerbations (Subgroups of Participants)(From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52))
  • Cumulative Asthma Exacerbation Days (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Rate of Asthma Exacerbations Associated With Hospitalizations (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Rate of Asthma Exacerbations Associated With Emergency Department/Urgent Care (ED/UC) Visits (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Number and Type of Asthma-related HRU (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))
  • Duration of Asthma-related Hospitalizations (Subgroups of Participants)(Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52))

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (38)

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