Comparison of the Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® HFA in Pediatric Patients With Persistent Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum observed plasma albuterol concentration (Cmax)
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.
详细描述
This is a single center, open-label, 2-period crossover study. The study consists of a screening visit followed by a treatment period comprising 2 treatment visits. The treatment period visits will be separated by a 4 to 14-day washout period. Eligible patients will be kept overnight prior to each treatment period.
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
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study-related procedure.
- •Male or pre-menarchal female patient 4-11 years of age, inclusive, as of the Screening Visit (SV)
- •Has a documented physician diagnosis of persistent asthma of a minimum of 3 months duration that has been stable for at least 4 weeks prior to the SV. The asthma diagnosis must be in accordance with the National Asthma Education and Prevention Program Guidelines Expert Panel Report 3 (EPR3).
- •Forced expiratory volume in 1 second (FEV1) >80% predicted for age, height and gender and race at the SV based on the pediatric population standards.
- •Any patient being treated with inhaled corticosteroids (ICS) must be on a lowdose regimen (200 mcg or less of fluticasone propionate per day or equivalent), which has been stable for at least 4 weeks prior to the SV and which is expected to be maintained for the duration of the study
- •Has required less than 4 inhalations per week of a rescue bronchodilator (on average) for the 4 weeks preceding the SV
- •Has the ability to withhold inhaled albuterol for at least 72 hours preceding each Treatment Visit (TV).
- •Other criteria apply, including must weigh at least 45 pounds
排除标准
- •A known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.)
- •Participation (receiving study drug) in any investigational drug trial within the 30 days preceding the SV or planned participation in another investigational drug trial at any time during this trial
- •History of severe milk protein allergy
- •Proneness to orthostatic dysregulation, syncope, or blackouts
- •History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has not resolved within 2 weeks preceding the SV.
- •History of life-threatening asthma or that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures
- •Any asthma exacerbation requiring systemic corticosteroids within 3 months of the SV. A patient must not have had any hospitalization for asthma within 6 months prior to the SV.
- •Other criteria apply.
研究组 & 干预措施
Spiromax/ProAir
Single dose of Albuterol Spiromax® 180 mcg followed by a 4 to 14 day washout period then a single dose of ProAir® HFA 180 mcg
干预措施: Albuterol Spiromax® (Drug)
Spiromax/ProAir
Single dose of Albuterol Spiromax® 180 mcg followed by a 4 to 14 day washout period then a single dose of ProAir® HFA 180 mcg
干预措施: ProAir® HFA (Drug)
ProAir/Spiromax
Single dose of ProAir® HFA 180 mcg followed by a 4 to 14 day washout period then a single dose of Albuterol Spiromax® 180 mcg
干预措施: Albuterol Spiromax® (Drug)
ProAir/Spiromax
Single dose of ProAir® HFA 180 mcg followed by a 4 to 14 day washout period then a single dose of Albuterol Spiromax® 180 mcg
干预措施: ProAir® HFA (Drug)
结局指标
主要结局
Maximum observed plasma albuterol concentration (Cmax)
时间窗: From baseline to up to 10 hours post dose
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
Area under the plasma albuterol concentration-time curve
时间窗: Time 0 to the last detectable plasma albuterol concentration measured up to 10 hours post-dose (AUC0-t)
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
次要结局
- Pharmacodynamic Effect on Vital Signs(From baseline to up to 6 hours post dose)
- Summary of participants with adverse events(From Day 1 to end of Follow-up Visit (approximately 4 weeks))