Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- AUC
研究概览
简要总结
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
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
- •With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
- •Must demonstrate response to beta 2 agonist by Reversing;
- •Must demonstrate ability to use DPI;
- •Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- •Additional Criteria
排除标准
- •Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
- •Upper respiratory tract infections
- •Asthma exacerbations;
- •Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
- •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;
- •Other Criteria
研究组 & 干预措施
T1
A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation
干预措施: albuterol inhalation powder (Drug)
T2
A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation
干预措施: albuterol inhalation powder (Drug)
T3
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
干预措施: albuterol inhalation powder (Drug)
T4
A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations
干预措施: albuterol inhalation powder (Drug)
P
Placebo, 2 inhalations
干预措施: Placebo (Drug)
R1
Proventil 90 mcg/inhalation, 2 inhalations
干预措施: albuterol inhalation aerosol (Drug)
R2
Proventil 90 mcg/inhalation, 4 inhalations
干预措施: albuterol inhalation aerosol (Drug)
结局指标
主要结局
AUC
时间窗: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.
次要结局
- Time to Effect(0 to 360 minutes)
- Hand Tremor(within 5 min. prior to dosing and 50 and 360 min post-dose.)
- Blood Work(within 15 min. prior to dosing, and 30 and 120 min. postdose)
- Response Rate(0 - 360 minutes)
- Vital Signs(within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.)
- Duration(0 - 360 minutes)
- 12 lead ECG(within 15 min. prior to dosing and at 50 and 360 min postdose.)
- Peak Response(0 - 360 minutes)