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Recruiting Not applicable

PULmonary Stimulation for Asthma Relief

NCT07709754 · tracked via the Priya Life Science USA tracker
Sponsor
Spiro Medical, Inc
Phase
Not applicable
Started
2026-08-30
Last updated
2026-10-13

Condition(s) studied

Moderate to Severe Asthma

Investigational drug(s) / intervention(s)

Spinal Cord Stimulation

Spinal Cord Stimulation: Implantation of a Spinal Cord Stimulation system

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 or 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

Primary outcome measure(s)

  • ACT score — 3 months
    Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score \>19

Trial sites (3)

FacilityCityRegionStatus
National Jewish Health Denver Colorado Not Yet Recruiting
University of Florida Health Gainesville Florida Recruiting
Orlando Health Orlando Florida Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07709754 on ClinicalTrials.gov ↗ ← All trials in the USA