A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change From Baseline in FEV1 AUC0-6
研究概览
简要总结
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
详细描述
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, 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
- •Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- •Oral corticosteroid use (any dose) within 6 weeks
- •Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
- •Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- •Historical or current evidence of a clinically significant disease
- •Cancer not in complete remission for at least 5 years
- •Hospitalized for psychiatric disorder or attempted suicide within 1 year
- •Unable to abstain from protocol-defined prohibited medications during the study
研究组 & 干预措施
• AS MDI 90 µg
(2 actuations of 45 µg/actuation)
干预措施: AS MDI 90 μg (Drug)
• AS MDI 180 µg
(2 actuations of 90 µg/actuation)
干预措施: AS MDI 180 µg (Drug)
• Placebo MDI
(2 actuations)
干预措施: Placebo MDI (Other)
• Proventil 90 µg
(1 actuation of 90 µg/actuation)
干预措施: Proventil 90 μg (Drug)
• Proventil 180 µg
(2 actuations of 90 µg/actuation)
干预措施: Proventil 180 μg (Drug)
结局指标
主要结局
Change From Baseline in FEV1 AUC0-6
时间窗: Over 6 hours post dose on Day 1
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
次要结局
- Peak Change From Baseline in FEV1(Over 6 hours post dose on Day 1)
- Change From Baseline in FEV1 AUC0-4(Over 4 hours post dose on Day 1)