NCT00118690已完成4 期
A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 51
- 主要终点
- Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.
研究概览
简要总结
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with persistent asthma for 3 months or longer.
- •Experience worsened asthma symptoms during physical activity.
- •Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).
排除标准
- •Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
- •Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
- •Admitted to a hospital within the last 6 months due to asthma symptoms.
- •Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
- •The study physician will evaluate other medical criteria.
结局指标
主要结局
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.
次要结局
- Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
研究者
研究点 (51)
Loading locations...
相似试验
已完成
4 期
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or ExerciseBronchospasmActivity/Exercise Induced BronchospasmNCT00118716GlaxoSmithKline248
已完成
4 期
Study Of Allergic Rhinitis In Patients Who Also Have AsthmaAsthmaNCT00296491GlaxoSmithKline725
已完成
4 期
Study Of Patients With Allergic Rhinitis And AsthmaAsthmaNCT00296530GlaxoSmithKline600
已完成
4 期
Study Of Asthma In Patients Of African DescentAsthmaNCT00102765GlaxoSmithKline479
已完成
4 期
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.Pulmonary Disease, Chronic ObstructiveNCT00355342GlaxoSmithKline186