A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,132
- 试验地点
- 1
- 主要终点
- Number of Participants With a Severe Asthma Exacerbation Event
研究概览
简要总结
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
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
- •Female or male aged ≥4 years at the time of informed consent
- •Physician diagnosis of asthma documented for at least 1 year
- •Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
- •Medium-to-high-dose inhaled corticosteroid (ICS)
- •Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
- •Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
- •Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted normal value for adults and adolescents, and ≥60 to <100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
- •Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
- •Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
- •A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
- •Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator
排除标准
- •Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- •Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
- •Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
- •Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
- •Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
- •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 of Visit 1
- •Historical or current evidence of a clinically significant disease
- •Cancer not in complete remission for at least 5 years
- •Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
- •History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
- •Significant abuse of alcohol or drugs
研究组 & 干预措施
BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
干预措施: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg (Combination Product)
BDA MDI (PT027) 80/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
干预措施: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg (Combination Product)
AS MDI (PT007) 180 µg
Albuterol sulfate MDI, PT007
干预措施: Albuterol sulfate metered-dose inhaler 180 μg (Drug)
结局指标
主要结局
Number of Participants With a Severe Asthma Exacerbation Event
时间窗: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (\<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.
次要结局
- Total Annualized Dose of Systemic Corticosteroid (SCS)(From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.)
- Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24(From baseline to Week 24)
- Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24(From baseline to 24 weeks)
- Annualized Severe Exacerbation Rate(From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.)