PULmonary Stimulation for Asthma Relief

NCT07709754 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 105-0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

asthma; severe asthma; neuromodulation

Outcome Measures

Primary Outcomes (1)

• ACT score

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

  3 months

Secondary Outcomes (1)

• Asthma related Quality of Life Questionnaire (AQLQ)

  3 months

Study Arms (2)

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.

Device: Spinal Cord Stimulation

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.

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

Implantation of a Spinal Cord Stimulation system

Also known as: Pulmonary Neuromodulation

Delayed activation arm; Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Spiro Medical, Inc.: lead

Study Sites (2)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Kurt Gehlsen, MD, PhD

CONTACT

520-904-8396; kgehlsen@spiromedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group will be activated at implantation. The other group will undergo delayed activation of their treatment, 3 months after implantation.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (2)