Efficacy, Dose-ranging and Safety Evaluation (A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Single Dose, Five-arm, Crossover, and 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
- 22
- 试验地点
- 4
- 主要终点
- Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose Baseline
研究概览
简要总结
This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
详细描述
This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a currently marketed Albuterol MDI product, will be used as an Active Control. The study also employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that it contains no active ingredient.
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
- 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 inhaled β-agonist(s) for asthma control
- •Demonstrating a Screening Baseline FEV1 at 50.0 - 85.0% of predicted normal
- •Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30 min after inhaling 2 actuations of Proventil® MDI (180 mcg) at Screening
- •Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
- •Demonstrating proficiency in the use of a DPI and an MDI after training
- •Females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
- •Having properly consented to participate in the trial
排除标准
- •A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening
- •Upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to Screening
- •Asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to Screening
- •Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
- •Concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
- •Known intolerance or hypersensitivity to any of the ingredients of the study drug DPI or Proventil® HFA MDI (i.e., Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, and ethanol)
- •Baseline ECG at Screening or Visit 1 showing any single or multiple premature ventricular contractions (PVC)
- •Baseline ECG at Screening or Visit 1 with a confirmed (through performing a second ECG) QTc reading greater than 450ms
- •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 prior to Screening.
研究组 & 干预措施
Treatment T1
One inhalation of 110 mcg A006 DPI. Total 110 mcg.
干预措施: A006 DPI (Drug)
Treatment T2
One inhalation of 220 mcg A006 DPI. Total 220 mcg.
干预措施: A006 DPI (Drug)
Placebo
One inhalation of placebo DPI . Total 0 mcg
干预措施: Placebo DPI (Other)
Treatment R1
One inhalation of Proventil® MDI Total 90 mcg
干预措施: Proventil® MDI (Drug)
Treatment R2
Two inhalations of Proventil® MDI, 180 mcg total
干预措施: Proventil® MDI (Drug)
结局指标
主要结局
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose Baseline
时间窗: Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule. Statistical analysis is performed using a one-sided t-test.
次要结局
- Time to Onset of Bronchodilator Effect (t[onset])(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Area Under the Curve (AUC[0-6h]) of Placebo Adjusted Post-Dose FEV1 Percentage Change (∆∆%FEV1) from the Same-Day Pre-Dose Baseline(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Volume Changes (∆FEV1) from the Same-Day Pre-Dose Baseline(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Peak Bronchodilator Response (F[max])(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Time to Peak ∆FEV1 Effect (t[max])(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- F[max] of Post-Dose FEV1 in Volume(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Efficacy Duration-1(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Efficacy Duration-2(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 in Volume from the Same-Day Pre-Dose Baseline(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Efficacy Duration-3(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Bronchodilator Response(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)
- Dose Response Curve(Within 30 minutes prior to dosing (baseline) to 6 hours post-dose)