An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
研究概览
简要总结
The primary objectives of this study are:
- To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma
- To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
- To compare the PK profiles of ABS between the 2 different strengths of TEV-56248
The secondary objective is:
• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
详细描述
The planned treatment duration for this trial is approximately 1.5 to 2 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.
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
- •Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit
- •Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit
- •Demonstrate acceptable inhalation technique with the training inhaler
- •Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3
- •Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)
- •Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device
- •NOTE- Additional criteria apply, please contact the investigator for more information
排除标准
- •Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures
- •Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial
- •Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
- •Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Sequence ABC
干预措施: Fp MDPI (Drug)
Sequence BCA
干预措施: Fp MDPI (Drug)
Sequence CAB
干预措施: Fp MDPI (Drug)
Sequence CBA
干预措施: Fp MDPI (Drug)
Sequence CBA
干预措施: TEV-56248 (Drug)
Sequence BAC
干预措施: TEV-56248 (Drug)
Sequence ACB
干预措施: TEV-56248 (Drug)
Sequence ACB
干预措施: Fp MDPI (Drug)
Sequence BAC
干预措施: Fp MDPI (Drug)
Sequence ABC
干预措施: TEV-56248 (Drug)
Sequence CAB
干预措施: TEV-56248 (Drug)
Sequence BCA
干预措施: TEV-56248 (Drug)
结局指标
主要结局
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
时间窗: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
时间窗: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
时间窗: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
时间窗: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
时间窗: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
时间窗: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
时间窗: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
时间窗: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
时间窗: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
时间窗: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
时间窗: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
时间窗: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
时间窗: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
时间窗: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
时间窗: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate
时间窗: Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
时间窗: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
时间窗: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
时间窗: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
时间窗: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
时间窗: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
时间窗: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
时间窗: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
时间窗: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
时间窗: Up to 24 hours postdose
次要结局
- Number of Participants with Adverse Events (AEs)(Up to 2 Months)
- Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)(Up to 2 Months)
- Number of Participants with Serious Adverse Events (SAEs)(Up to 2 Months)