PULmonary Stimulation for Asthma Relief

Official title

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

Overview

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Detailed description

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.

Interventions

• Device Spinal Cord Stimulation
  Implantation of a Spinal Cord Stimulation system

Primary outcome measures

• ACT score [Time frame: 3 months]

Secondary outcome measures (1)

• Asthma related Quality of Life Questionnaire (AQLQ) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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 exclusion criteria
• 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

• BMI> 35
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• National Jewish Health — Denver
• University of Florida — Gainesville

Identifiers

NCT: NCT07709754 · 105-0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗