PULmonary Stimulation for Asthma Relief (PULSAR)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Moderate to Severe Asthma
• Intervention / Treatment: Device: Spinal Cord Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kurt Gehlsen, MD, PhD; Phone Number: 520-904-8396; Email: kgehlsen@spiromedical.com

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
      • Principal Investigator: Michael E Wechsler, MD
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Spinal Cord Stimulation; Implantation of a Spinal Cord Stimulation system; Other Names: Pulmonary Neuromodulation
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.	Device: Spinal Cord Stimulation; Implantation of a Spinal Cord Stimulation system; Other Names: Pulmonary Neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACT score	Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score >19	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma related Quality of Life Questionnaire (AQLQ)	Proportion of subjects within each group who achieve a clinically meaningful improvement in AQLQ	3 months

Collaborators and Investigators

• Sponsor: Spiro Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: asthma; neuromodulation; severe asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Spinal Cord Stimulation
• Other Study ID Numbers: 105-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes