Moderate to Severe AsthmaPULSARNCT07709754
PULmonary Stimulation for Asthma Relief
A study testing Spinal Cord Stimulation in people with Moderate to Severe Asthma, run by Spiro Medical, Inc. at 3 sites in United States.
Trial summary
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Asthma
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Aug 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
National Jewish Health
Denver, Colorado, 80206
Michael E Wechsler, MD
- Recruiting
University of Florida Health
Gainesville, Florida, 32608
Andrew Kline, 724-496-8034, andrew.kline@neurosurgery.ufl.edu
Daryl Fields, MD, PhD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Thomas L Melendez, 407-687-6698, Thomas.Melendez@orlandohealth.com
Bruce Dixon, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Moderate to Severe Asthma
- Being tested
- Spinal Cord Stimulation
- Keywords
- asthma, severe asthma, neuromodulation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Also called Pulmonary Neuromodulation
Implantation of a Spinal Cord Stimulation system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT score
Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score >19
Measured: 3 months
Secondary outcomes (1)
Asthma related Quality of Life Questionnaire (AQLQ)
Proportion of subjects within each group who achieve a clinically meaningful improvement in AQLQ
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start30 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One group will be activated at implantation. The other group will undergo delayed activation of their treatment, 3 months after implantation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spiro Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709754
- Sponsor's protocol ID
- 105-0001
- Acronym
- PULSAR
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07709754
- Acronym / sponsor ID
- PULSAR / 105-0001
- Conditions
- Moderate to Severe Asthma
- Keywords
- asthma, severe asthma, neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Spiro Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One group will be activated at implantation. The other group will undergo delayed activation of their treatment, 3 months after implantation.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Spinal Cord StimulationReceives 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. |
| Delayed activation arm | Sham comparator | Device: Spinal Cord StimulationReceives 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationAlso: Pulmonary NeuromodulationImplantation of a Spinal Cord Stimulation system | Device | Delayed activation arm, Treatment arm |
Primary outcome
ACT score
Time frame: 3 months
Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score >19
1 secondary outcome
Asthma related Quality of Life Questionnaire (AQLQ)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Moderate to Severe Asthma, run by Spiro Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kurt Gehlsen, MD, PhD (949-421-6584, clinical@spiromedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACT score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.