Recruiting

Pulmonary Neuromodulation

Sponsor:

Spiro Medical, Inc.

Code:

NCT07709754

Conditions

Moderate to Severe Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulation

Study Details

Brief summary:

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

Conditions

Moderate to Severe Asthma

Study ID

NCT07709754

Start date

Aug 30, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm

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.

sham comparator: Delayed activation arm

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.

Interventions

Spinal Cord Stimulation

Implantation of a Spinal Cord Stimulation system

Primary outcome measure

  • ACT score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Kurt Gehlsen, MD, PhD

949-421-6584clinical@spiromedical.com

Locations

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Andrew Kline

724-496-8034andrew.kline@neurosurgery.ufl.edu

Principal Investigator:

Daryl Fields, MD, PhD

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Thomas L Melendez

407-687-6698Thomas.Melendez@orlandohealth.com

Principal Investigator:

Bruce Dixon, MD

More Information

Sponsor

Spiro Medical, Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • asthma
  • severe asthma
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Spiro Medical, Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.