Could a spinal implant tame Hard-to-Control asthma?
NCT ID NCT07709754
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study tests whether a device that stimulates the spinal cord — called pulmonary neuromodulation — can improve asthma control in adults with moderate to severe asthma that remains uncontrolled despite high-dose inhalers or biologic medications. Participants receive the implanted device and are randomly assigned to have it activated immediately or after a delay. The main goal is to see if more people achieve a meaningful improvement in their Asthma Control Test score.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a spinal cord stimulation device (pulmonary neuromodulation)
- What this could lead to
- If effective, this device could offer a new option for people whose asthma remains poorly controlled despite standard medications.
- What could go wrong
- This is a small early feasibility study with only 30 participants, so results may not apply widely. The device requires surgical implantation, which carries risks such as infection or device-related complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Jewish Health
Denver, Colorado, 80206, United States
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University of Florida
Gainesville, Florida, 32611, United States
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