A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period
研究概览
简要总结
This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from at least one parent/ legal guardian to take part in the study.:
- •Diagnosis of asthma
- •pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
- •Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)
排除标准
- •history of life-threatening asthma
- •history of asthma exacerbation for asthma within 6 months prior to screening.
- •Culture-documented or suspected bacterial or viral infection
- •significant abnormality or medical condition
- •Present use of any tobacco products
研究组 & 干预措施
Arm 1
Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Fluticasone propionate 100mcg (Drug)
Arm 1
Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Vilanterol (Drug)
Arm 2
Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Fluticasone propionate 100mcg (Drug)
Arm 2
Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Vilanterol (Drug)
Arm 3
Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Fluticasone propionate 100mcg (Drug)
Arm 3
Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Vilanterol (Drug)
Arm 4
Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Fluticasone propionate 100mcg (Drug)
Arm 4
Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period
时间窗: Baseline; Week 1 up to Week 4
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.
次要结局
- Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period(Baseline; Week 1 up to Week 4)
- Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver(Baseline; Week 4)
- Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period(Baseline; Week 1 up to Week 4)
- Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period(Baseline; Week 1 up to Week 4)
- Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)(Baseline; Week 4)
- Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)(Baseline; Week 4)