NCT07709754招募中不适用
Randomized, Controlled, Multi-Center, Delayed Activation Feasibility Clinical Study to Evaluate the Safety and Efficacy of Pulmonary NeuroModulation (PNM) for the Treatment of Subjects With Moderate to Severe Uncontrolled Asthma - PULSAR: Pulmonary Stimulation for Asthma Relief
Spiro Medical, Inc.4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- ACT score
研究概览
简要总结
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma
详细描述
The study will be a prospective, randomized, controlled, multi-Center, delayed activation feasibility study.
The study is expected to complete enrollment in approximately 3 months and follow the patients per protocol for 6 months. The study will be conducted at 3-5 sites in the United States.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of uncontrolled moderate to severe asthma, diagnosed by an Allergist or Pulmonologist, for a minimum of 1 year prior to randomization. "Uncontrolled" status defined by poor symptom control, despite optimized treatment with high-dose ICS-LABA and/or biologics who have a baseline ACT score less than or equal to 15
- •Subjects previously or currently on biologics for at least 6 months (Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab, Tezepelumab) that are uncontrolled and meet all inclusion and
排除标准
- •18 to 75 years of age
- •Subjects have a baseline AQLQ of less than 2.5
- •Subject is a surgical candidate with no contraindications for PNM implantation
- •Exclusion Criteria:
- •Current smokers or subjects with a significant smoking history (e.g., >10 pack years for subjects less than 40 years of age and >15 pack years for subjects 40 years and older) who have smoked within the last 6 months.
- •Other chronic lung diseases including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), chronic bronchitis, vocal cord dysfunction, eosinophilic granulomatosis with polyangiitis (EGPA), history of lung cancer, or interstitial lung disease, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
- •Requires continuous anticoagulant medications or taking alternative anticoagulant drugs or supplements within 10 days of implantation
- •History of recurrent surgical infections (e.g. MRSA)
- •In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, or systemic corticosteroids.
- •Patients prescribed systemic corticosteroids for any condition, other than asthma, in the last 6 weeks. Subjects with asthma on oral corticosteroids taking more than 15mg/day.
- •Significant coronary artery occlusive disease, angina, history of myocardial infarction and/or coronary artery stent(s), congestive heart failure, or uncontrolled cardiac arrythmias, cardiac stress test within the last 6 months with an Ejection Fraction of less than 45%
- •History of thoracic spine surgery and has no spinal abnormalities, i.e., no more than 5 lumbar vertebrae, no scoliosis, or spinal deformities
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain, etc.) or a medical condition that requires the subject to be treated with systemic opioids other than for post-surgical pain
- •Any neurological condition that could interfere with normal lung function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- •Uncontrolled diabetes (A1C > 8%, documented in the last three (3) months) or other medical condition determined by the Investigator that should be excluded
- •Documented history of allergic response to titanium, platinum, polyurethane, epoxy, or silicone
- •Planning to have diathermy, surgery requiring electrocautery, or high output ultrasonic exposure during the course of the study
- •Any other implanted devices (e.g., drug delivery pumps, pacemaker, ICD) including neurostimulators whether turned on or off. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site, both the IPG or lead.
- •A female with a positive urine pregnancy test or not using adequate contraception
- •Currently participating in another treatment clinical trial
- •Subject lacks capacity to consent for themselves
研究组 & 干预措施
Treatment arm
Experimental
Receives full Spinal Cord Stimulation implant on Day 0. Therapy is activated on Day 0. Safety and efficacy are assessed at 2 weeks, 1 month, 3 months, 4 months, 5 months and 6 months.
干预措施: Spinal Cord Stimulation (Device)
Delayed activation arm
Sham Comparator
Receives full Spinal Cord Stimulation implant on Day 0. Therapy is activated on Day 90. Safety and efficacy are assessed at 2 weeks, 1 month, 3 months, 3.5 months, 4 months, 5 months and 6 months.
干预措施: Spinal Cord Stimulation (Device)
结局指标
主要结局
ACT score
时间窗: 3 months
Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score \>19
次要结局
- Asthma related Quality of Life Questionnaire (AQLQ)(3 months)
研究者
研究点 (4)
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