A 12-week Comparison of the Efficacy and Safety and Steady-State Pharmacokinetics of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 35
- 主要终点
- Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent
- •At least 12 years of age at screening
- •General good health
- •Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
- •Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
- •Ability to perform spirometry in an acceptable manner as per protocol guidelines
- •Other inclusion criteria apply
排除标准
- •A known hypersensitivity to albuterol or any of the excipients in the formulations.
- •History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
- •History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
- •Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
- •Hospitalization due to asthma exacerbation 2 or more times in the past year
- •Initiation of immunotherapy or dose escalation during the study period
- •Other exclusion criteria apply.
研究组 & 干预措施
Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
干预措施: Placebo MDPI (Drug)
Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
干预措施: Albuterol MDPI (Drug)
结局指标
主要结局
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
时间窗: Day 1, Day 8 and Day 85
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
次要结局
- Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1(Day 1)
- Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8(Day 8)
- Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85(Day 85)
- Participants With Adverse Events(Day 1 to Day 93)
- Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group(Day 1 (Baseline), Day 85)
- Participants With Clinically Significant Vital Sign Assessments(Days 8 and 85)
- Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8(Days 1 and 8)
- Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8(Days 1 and 8)
- Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8(Days 1 and 8)
- Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8(Days 1 and 8)
- Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8(Days 1 and 8)
- Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1(Day 1)
- Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8(Day 8)