Asthma Control in Severe Asthma Patients Treated With Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 513
- 试验地点
- 58
- 主要终点
- Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75)
研究概览
简要总结
A study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma. This study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (PRO).
详细描述
This is a 12-month, multi-country, multi-center, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess asthma symptom control, lung function, and patient-reported outcomes including health-related quality of life after tezepelumab treatment initiation in participants with severe asthma in Europe and Canada. This study is planned to be conducted in several countries including but not limited to Canada, Germany, Denmark, Switzerland, and Sweden.
Participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 participants aged 12 years or older
- •Provision of signed and dated written informed consent, including assent for minors
- •Prescribed treatment with Tezepelumab
- •Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses
- •Received at least one prescription of medium-dose to high-dose inhaled corticosteroids (ICS) during the 52 weeks prior to enrolment date
- •Use of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment date
- •Documented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment date
- •Individuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment
- •Participants currently receiving care from pulmonologists and/or allergists
- •Participants who are able to understand and complete the ePROs
- •Availability of participants medical records for asthma exacerbation and Healthcare Resource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiation
排除标准
- •Any contraindication to Tezepelumab
- •Participants on concurrent biologics for asthma at the time of receiving the first dose of Tezepelumab will be excluded except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment)
- •Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months
- •Pregnancy or lactation period.
研究组 & 干预措施
Prospective Cohort
Participants with severe uncontrolled asthma will receive tezepelumab. Relevant demographics, baseline clinical data, and asthma control questionnaire-6 (ACQ-6) will be retrospectively collected. All patient reported outcomes (PROs) will be prospectively collected. Other outcomes of interest (tezepelumab patterns of utilization, lung function, asthma exacerbations, medication use, and healthcare resource utilization [HRU]) will be collected at baseline (retrospective collection for 52-week pre-index period during enrolment) and prospectively collected during enrolment for participants who enroll into the study before the first dose of tezepelumab, and for a period of up to 52 weeks (at Weeks 4, 12, 24, and 52) after the index date. The index date is defined as the date when participants receive the first dose of tezepelumab.
干预措施: None (Observational Study) (Other)
结局指标
主要结局
Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75)
时间窗: Week 52
Participant-reported asthma symptom control using ACQ-6 will be described.
Number of participants with improvement in ACQ-6 response score
时间窗: From Baseline (Week -52 to Week 0) to Week 52
Improvement from baseline in ACQ-6 score of \>=0.5 will be described.
Change in Asthma Control Questionnaire 6 (ACQ-6) score from Baseline
时间窗: From Baseline (Week -52 to Week 0) to Week 52
Participant-reported asthma symptom control using ACQ-6 will be described. The minimum value of ACQ-6 score is 0 and the maximum value of ACQ-6 score is 6. The ACQ-6 score of 0 indicates well tolerated asthma whereas, the ACQ-6 score of 6 indicates extremely poorly controlled asthma
Time to first ACQ-6 response
时间窗: From Baseline (Week -52 to Week 0) to Week 52
Time to first ACQ-6 response will be assessed. The ACQ-6 response is defined as change from baseline in ACQ-6 score \<= -0.5.
Asthma Control Questionnaire (ACQ-6) score
时间窗: Week 52
Participant-reported asthma symptom control using ACQ-6 will be described. The ACQ-6 was developed for self-administration by adults and adolescents by omitting the forced expiration volume in 1 second (FEV1) % predicted question. Patients are asked to record their experience with 5 symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of short-acting. β2 agonist over the previous week using a 7-point scale (0 = no impairment; 6 = maximum impairment). The ACQ-6 score is calculated by taking the mean of the 6 equally weighted items. The ACQ-6 score range is 0 (well controlled) to 6 (extremely poorly controlled).
次要结局
- Change from baseline in SGRQ total score(From Baseline (Week -52 to Week 0) to Week 52)
- Change from baseline in ACT total score(From Baseline (Week -52 to Week 0) to Week 52)
- Number of participants with improvement in SGRQ total score(From Baseline (Week -52 to Week 0) to Week 52)
- Number of participants with improvement in ACT total score(From Baseline (Week -52 to Week 0) to Week 52)
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1)(Week 52)
- Post-BD FVC(Week 52)
- Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with asthma exacerbations(From Baseline (Week -52 to Week 0) to Week 52)
- Median SCS or ICS dose change(From Baseline (Week -52 to Week 0) to Week 52)
- Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS(From Baseline (Week -52 to Week 0) to Week 52)
- Annualized rates of asthma-related visits leading to hospitalization and emergency department (ED) visits, urgent care visits, or unscheduled out-patient or physician visits(Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52)
- Annualized rates of asthma related physician/healthcare calls/visits(From Baseline (Week -52 to Week 0) to Week 52)
- Duration of asthma-related hospitalisation(From Baseline (Week -52 to Week 0) to Week 52)
- St. George's Respiratory Questionnaire (SGRQ) total score(Week 52)
- Changes from baseline in pre-BD FEV1(From Baseline (Week -52 to Week 0) to Week 52)
- Changes from baseline in pre-BD FVC(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with spirometry and/or body plethysmography parameters(Week 52)
- Annualized asthma exacerbation rate (AAER)(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with reduced total number of asthma exacerbations(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants who completed 52 weeks of tezepelumab treatment with at least 50% reduction in exacerbations(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with tezepelumab discontinuation and reason(s)(From Baseline (Week -52 to Week 0) to Week 52)
- Time to tezepelumab discontinuation(From Baseline (Week -52 to Week 0) to Week 52)
- Asthma Control Test (ACT) total score(Week 52)
- Number and type of asthma related healthcare resource utilization (HCRU)(Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52)
- Changes from baseline in post-BD FEV1(From Baseline (Week -52 to Week 0) to Week 52)
- Changes from baseline in post-BD FVC(From Baseline (Week -52 to Week 0) to Week 52)
- Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)(Week 52)
- Change from baseline in AAER(Baseline (Week -52 to Week 0) to Week 52)
- Pre BD forced vital capacity (FVC)(Week 52)
- Pre-BD forced expiratory flow (FEF)(Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52)
- Changes from baseline in pre-BD FEF(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants who completed 52 weeks of tezepelumab treatment without an asthma exacerbation(From Baseline (Week -52 to Week 0) to Week 52)
- Cumulative asthma exacerbation days(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with any systemic corticosteroid (SCS) or inhaled corticosteroid (ICS) use(From Baseline (Week -52 to Week 0) to Week 52)
- Number of participants with categorised percent reduction on cumulative systemic corticosteroids (SCS) dose(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with stable disease(From Baseline (Week -52 to Week 0) to Week 52)
- Duration (days) of tezepelumab treatment(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with switching to other biologics for asthma and reasons(s)(From Baseline (Week -52 to Week 0) to Week 52)
- Proportion of participants with long-term SCS and ICS use(From Baseline (Week -52 to Week 0) to Week 52)