A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 18
- 主要终点
- AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
研究概览
简要总结
The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.
详细描述
A prospective, sequential two phase multicenter, randomized double-blind, safety, & feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD with 30% ≤ FEV1 < 60% and FEV1/FVC <70% (post-bronchodilator);
- •Patient ≥ 40 and ≤ 75 years of age at the time of consent;
- •The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
- •Smoking history of at least 10 pack years;
- •Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
- •Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;
排除标准
- •Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
- •History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
- •Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
- •Documented history of asthma diagnosed with onset <30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
- •Pulmonary nodule requiring follow-up or intervention unless proven benign;
- •Daily use of >10 mg of prednisone or its equivalent at the time of enrollment;
研究组 & 干预措施
Targeted Lung Denervation
active targeted lung denervation
干预措施: Holaira™ Lung Denervation System with energy delivery (Device)
Sham-Control
non-active targeted lung denervation
干预措施: Holaira™ Lung Denervation System without energy delivery (Device)
结局指标
主要结局
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
时间窗: 3-6.5 months
Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.
次要结局
- Device Success(6 months)
- Spirometry measures(3 years)
- Procedure Success(Through discharge)
- CT Scan assessment(3 years)
- Adverse events over 3 years(3 years)
- Change in Functional testing: Cycle Ergometry & 6MWT(3 years)
- Heath-related Quality of Life (SGRQ-C & EQ-5D)(3 years)
- Plethysmography measures(3 years)