A 6-week Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Fluticasone 250μg/Salmeterol 50μg Combination (FSC 250/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dyspnea intensity (Borg rating at a standardized time during exercise)
研究概览
简要总结
Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy [i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable mild COPD,
- •FEV1/FVC<0.7 and FEV1>60% predicted,
- •Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score <9, MRC dyspnea scale >2),
- •Cigarette smoking history ≥20 pack-years.
排除标准
- •Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
- •Important contraindications to clinical exercise testing,
- •Use of daytime oxygen,
- •History of Asthma.
研究组 & 干预措施
FSC 250/50
fluticasone 250μg/salmeterol 50μg combination
干预措施: fluticasone/salmeterol combination (Drug)
Placebo
matched placebo inhaler
干预措施: placebo (Drug)
结局指标
主要结局
Dyspnea intensity (Borg rating at a standardized time during exercise)
时间窗: 6 weeks
次要结局
- Exercise endurance time(6 weeks)
- Measurements of small airway function(6 weeks)
- Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics(6 weeks)
研究者
Dr. Denis O'Donnell
Principal Investigator
Queen's University