A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,772
- 试验地点
- 732
- 主要终点
- Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
研究概览
简要总结
The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).
Secondary Objectives:
To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure
To evaluate the safety and tolerability of Fp/A BS
The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
- •The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month.
- •The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit).
- •If female, the participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the study), or is of nonchildbearing potential
- •NOTE- Additional criteria apply, please contact the investigator for more information.
排除标准
- •The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.
- •The participant has a suspected bacterial or viral infection (other than Coronavirus Disease [COVID-19]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.
- •Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19").
- •The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening.
- •The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months.
- •The participant has significantly abused alcohol and/or illicit prohibited drugs within the previous 24 months.
- •The participant has participated as a randomized participant in any investigational drug study within 30 days.
- •The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Albuterol sulfate
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: Albuterol sulfate (Drug)
TEV-56248 Low Dose
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: TEV-56248 (Drug)
TEV-56248 High Dose
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: TEV-56248 (Drug)
TEV-56248 30/117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: TEV-56248 (Drug)
TEV-56248 55/117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: TEV-56248 (Drug)
Albuterol sulfate 117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
干预措施: Albuterol sulfate (Drug)
结局指标
主要结局
Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
时间窗: Up to 42 months
次要结局
- Asthma Control Questionnaire-5 (ACQ-5) Response(Baseline, Week 24)
- Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)(Baseline, Week 24)
- Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI(Up to 42 months)
- Annualized Severe CAE Rate(Up to 42 months)
- Total Annualized SCS Exposure Over the Treatment Period(Up to 42 months)
- Number of Participants with at Least One Adverse Event(Up to 42 months)
- Number of Participants with at Least One Serious Adverse Event(Up to 42 months)
- Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events(Up to 42 months)