Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Transition Dyspnea Index
研究概览
简要总结
Multi-site, randomized controlled trial to determine whether patients who report NO symptomatic benefit with their maintenance hand-held inhaler(s), benefit upon switching to nebulized therapy using comparable classes of medications.
详细描述
In stable out-patients with an established diagnosis of severe to very severe COPD the hypothesis is that delivery of similar long-acting, maintenance medications via a breath-enhanced jet nebulizer provides significant improvements in ratings of dyspnea and health status compared with continuing therapy with handheld device(s).
This hypothesized benefit could be due to:
Patients with severe to very severe COPD may not consistently use their handheld inhaler(s) correctly every day and therefore not achieve optimal bronchodilation/symptom benefit; and/or A breath-enhanced jet nebulizer can deliver smaller size particles and a greater fine particle fraction (< 5 μm) than handheld therapy in patients with COPD using Acceptable technique.
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
- Single (Outcomes Assessor)
盲法说明
DELIVERY is an open-label study with an outcomes assessor blinded to treatment arm.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 10 pack-years smoking cigarettes
- •Diagnosis of COPD based on GOLD Criteria
- •Patients are clinically stable for the past 4 weeks
- •Prior Pulmonary function tests showing FEV1 < 50% predicted (either 30 minutes post albuterol or within 2-4 hours after using their maintenance long-acting inhaler) within the past 12 months.
- •Currently using a single pMDI or a single DPI with either LABA/LAMA or LABA/LAMA/ICS therapy for at least one month.
排除标准
- •Current diagnosis of dementia or known cognitive impairment.
- •Current impairment in manual dexterity (i.e., severe rheumatoid arthritis, severe tremor, etc)
- •Exacerbation of COPD within the last 2 months
- •Current diagnosis of other respiratory disease including asthma, treatment with a LABA/LAMA slow mist inhaler or treatment with SABA/SAMA nebulizer medications 3-4 times per day as maintenance therapy
- •Current use of daily Prednisone as treatment for COPD
研究组 & 干预措施
Handheld Inhaler Group
Subjects continue with their current maintenance handheld inhaler regimen
干预措施: Continue handheld therapy (Device)
Nebulizer Group
Subjects switched to nebulized therapy using similar medication solutions
干预措施: Nebulized therapy of similar medication solutions (Device)
结局指标
主要结局
Transition Dyspnea Index
时间窗: 28 (+/- 2) days
Measurement of dyspnea
次要结局
- FEV1 and FVC(28 (+/- 2) days)