A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Change in FEV1 Area Under the Curve (AUC) versus placebo
研究概览
简要总结
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.
详细描述
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.
The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.
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
- •Generally healthy, male and female adults, 18-55 years of age at screening
- •With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
- •Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
- •Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
- •Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
- •Demonstrate ability to use a DPI and MDI inhaler properly after training
- •Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
- •Properly agree to participate in the trial
排除标准
- •A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
- •Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
- •Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
- •Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
- •Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
- •Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)
研究组 & 干预措施
T1
Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg
干预措施: Albuterol DPI 25 mcg/inh (Drug)
T1
Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg
干预措施: Placebo DPI (Drug)
T2
Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg
干预措施: Albuterol DPI 25 mcg/inh (Drug)
T3
Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg
干预措施: Albuterol DPI 90 mcg/inh (Drug)
T3
Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg
干预措施: Placebo DPI (Drug)
T4
Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg
干预措施: Albuterol DPI 90 mcg/inh (Drug)
P
Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg
干预措施: Placebo DPI (Drug)
R1
One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg
干预措施: Albuterol MDI 90 mcg/inh (Drug)
R2
Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg
干预措施: Albuterol MDI 90 mcg/inh (Drug)
结局指标
主要结局
Change in FEV1 Area Under the Curve (AUC) versus placebo
时间窗: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
次要结局
- AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7(Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose)
- Placebo AUC of adjusted FEV1 changes(Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose)
- Duration of effect(Visits 1-7 at 5, 20, 30, 60, 90, 120, 180 and 360 minutes post-dose)
- Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline(Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose)
- Vital Signs (i.e.: blood pressure and heart rate)(Visits 1-7 and EOS at baseline, 3, 8, 15, 30, 90 and 360 minutes post-dose)
- Serum potassium(Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose)
- Peak bronchodilator response (Fmax)(Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose)
- Time to peak FEV1 effect (tmax)(Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose)
- Asthma exacerbation incidents(Visits 1-7 and EOS)
- Asthma management/ rescue drug usage(Visits 1-7 and EOS)
- CBC(Screening and End-of-Study Visit)
- Bronchodilatory Response Rate (R percent)(Visits 1-7 at 60 minutes)
- Dose response curve: AUC of change in percent FEV1 versus Dose(Visits 1-7)
- 12-lead ECG (for routine and QT/QTc)(Visits 1-7 at baseline, 10, 50 and 360 minutes post-dose)
- Serum glucose(Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose)
- Physical examination(Screening and End-of-Study Visit)
- Comprehensive metabolic panel(Screening and End-of-Study Visit)
- Urinalysis(Screening and End-of-Study Visit)
- Pregnancy test(Screening and End-of-Study Visit)
- Medication interactions(Screening, Visits 1-7 and End-of-Study Visit)
- Number of participants with adverse events as a measure of safety and tolerability(Screening, Visits 1-7, End-of-Study Visit)