COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
研究概览
简要总结
The main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant COPD.
详细描述
Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be enrolled; a total of 40 subjects is planned.
Subjects will all have background ipratropium-albuterol administered four times daily. Subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.
The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest CT scan gas trapping as an exploratory outcome.
The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD GOLD Stage 2 and 3 (post-bronchodilator FEV1 35-80% predicted and FEV1/FVC <0.7 at the time of enrollment in COPDGene) by spirometry.
- •Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema)
- •Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease).
- •No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid.
- •Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed).
排除标准
- •Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks.
- •Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications.
- •Symptomatic, untreated benign prostate hypertrophy.
- •Allergy to peanuts.
研究组 & 干预措施
ipratropium/albuterol
1 puff 4 times daily
干预措施: Ipratropium/albuterol (Drug)
Budesonide
budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
干预措施: Budesonide (Drug)
Budesonide
budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
干预措施: Ipratropium/albuterol (Drug)
budesonide/formoterol
budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
干预措施: budesonide/formoterol (Drug)
budesonide/formoterol
budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily
干预措施: Ipratropium/albuterol (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
时间窗: 12 weeks
FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose budesonide and budesonide/formoterol
次要结局
- Health Status(12 weeks)
- Dyspnea(12 weeks)
- CT scan gas trapping(Before and 12 weeks after randomization)
- Post-bronchodilator FEV1(12 weeks)
- Patient reported adverse events(12 weeks)
- Forced vital capacity (FVC) pre-bronchodilator(12 weeks)
- Six minute walk distance(12 weeks)
- Patient-reported exacerbations(12 weeks)
- Post-bronchodilator FVC(12 weeks)