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

GlaxoSmithKline Research & Development Ltd.0 个研究点目标入组 1,012 人开始时间: 2016年12月8日最近更新: 2016年12月12日

适应症

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 456
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Hospital admission for asthma within 3 months prior to Visit 1.
•- Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
•- Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.

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