A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Cumulative-dose, Dose-escalating, Three-arm, Cross-over Study, in 24 Asthma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg.
研究概览
简要总结
The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
- •Sitting blood pressure ≤ 135/90 mmHg;
- •Demonstrating negative alcohol/drug screen tests;
- •Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
- •With mild-to-moderate persistent asthma for at least 6 months prior to Screening, and having used inhaled β-agonist(s) for asthma control;
- •Demonstrating a Mean Screening Baseline FEV1 at 50.0 - 85.0 % of predicted normal;
- •Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30(±5) min after inhaling 2 actuations of Proventil-HFA;
- •Demonstrating Peak Inspiratory Flow Rate within 80-150 L/min;
- •Demonstrating proficiency in the use of DPI and MDI after training;
- •Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- •Having properly consented to participate in the trial.
排除标准
- •Smoking history of ≥ 10 pack-years, or having smoked within 6 months prior to Screening;
- •Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk;
- •Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior;
- •Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs, besides asthma;
- •Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignancies, or other illnesses that could impact on the conduct, safety and evaluation of the study;
- •Known intolerance or hypersensitivity to any of the ingredients of the A006 or Proventil-HFA;
- •Use of prohibited drugs or failure to observe the drug washout restrictions;
- •Having been on other clinical drug/device studies in the last 30 days;
- •Having donated blood within the last 30 days prior to Screening.
研究组 & 干预措施
T
Four doses of A006 taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.
干预措施: A006 (Drug)
R
Four doses of Proventil-HFA taken in 30 minute intervals. Doses will have an escalating number of inhalations (2, 2, 4, and 8 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.
干预措施: Proventil-HFA (Drug)
P
Four doses of Placebo DPI taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 0 mcg.
干预措施: Placebo DPI (Drug)
结局指标
主要结局
Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg.
时间窗: -15 min predose, 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, 360 min post dose 4
Area Under the Curve (AUC)0-t of percent change in Forced Expiratory Volume in 1 second (FEV1), which is defined as the area under curve of post-dose FEV1 percentage changes from the Pre-dose Baseline FEV1 (FEV10) versus time. Doses are at 0, 30, 60 and 90 min.
次要结局
- AUC0-t of change in FEV1(-15, 15 min post 1, 2, and 3, and 15, 90, 120, 240, and 360min post dose 4)
- Time to onset(0 - 120 min)
- Peak Response(15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, and 360 min post dose 4)
- Adverse Events(Time 0, 15, 45, 75, 105, 150, 195, 130, 190, 250, 435 minutes post dose 1)
- Vital Signs and Electrocardiogram (ECG)(-15, 5, 35, 65, 100, 155, 275, 455, 815 min post dose 1)
- Blood Analysis(-15, 10, 25,40, 55, 70, 85, 95, 115, 145, 175, 210, 270, 330, 690 min post dose 1)