Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 27
- 主要终点
- Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
研究概览
简要总结
This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
详细描述
Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age 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
- Double
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
- •Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
- •More than or 12% FEV1 reversibility following inhalation of salbutamol.
- •Must also be symptomatic on short-acting beta-agonists.
- •Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.
排除标准
- •Hospital admission for asthma within 3 months prior to Visit
- •Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit
- •Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.
结局指标
主要结局
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
次要结局
- Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR