NCT00238082终止不适用
The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
研究概览
简要总结
This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis
- •FEV1/FVC<70%
- •FEV1 50-80% predicted
- •Albuterol response of <12% and <200mL or methacholine PC20 > 8mg/mL
- •RV > 120% predicted
- •DLCO < 80%
- •smokers and nonsmokers
- •Lower age limit 45 years
排除标准
- •Other chronic airway or parenchymal lung disease
- •Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
- •Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
- •Use of theophylline, leukotriene modifiers within 12 weeks
- •Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)
结局指标
主要结局
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Spirometric response (FEV1)
次要结局
未报告次要终点
研究者
研究点 (2)
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