NCT00920543已完成4 期
A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Salmeterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Average inhaled corticosteroid treatment dose over the treatment period
研究概览
简要总结
The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects 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 (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma diagnosis
- •Controller medications or moderate inhaled corticosteroid dose
- •Evidence of reversibility
排除标准
- •Life-threatening asthma
- •Asthma instability
- •Concurrent respiratory disease
- •Drug allergy
- •Respiratory tract infection
- •Systemic corticosteroid use
- •Immunosuppressive medication use
- •Positive pregnancy test
- •Tobacco use
- •Site affiliation
研究组 & 干预措施
Fluticasone propionate
Active Comparator
干预措施: Placebo (Drug)
Fluticasone propionate
Active Comparator
干预措施: FP 100mcg (Drug)
Fluticasone propionate
Active Comparator
干预措施: FP 500mcg (Drug)
Fluticasone propionate
Active Comparator
干预措施: FP 250mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
干预措施: Placebo (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
干预措施: FSC 100/50mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
干预措施: FSC 250/50mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
干预措施: FSC 500/50mcg (Drug)
结局指标
主要结局
Average inhaled corticosteroid treatment dose over the treatment period
时间窗: Every 8 weeks for the 40 week treatment period
次要结局
- Pulmonary function measures(Every 8 weeks for the 40 week treatment period)
研究者
研究点 (1)
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