30 Participants NeededMy employer runs this trial

Pulmonary Neuromodulation for Asthma

(PULSAR Trial)

Recruiting at 2 trial locations
KG
Overseen ByKurt Gehlsen, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spiro Medical, Inc.
Must be taking: ICS-LABA, Biologics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called Pulmonary Neuromodulation, which targets the nervous system in the lungs, to determine its safety and effectiveness for people with moderate to severe asthma. The study will compare two groups: one starting the treatment immediately and another starting later. Individuals who have experienced moderate to severe asthma for at least a year, struggle to control symptoms despite high-dose medications or biologics, and find that asthma frequently disrupts daily life might be suitable candidates.

As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to new treatment options.

What prior data suggests that Pulmonary Neuromodulation is safe for asthma patients?

Research has shown that Pulmonary Neuromodulation for asthma is generally safe. Most participants in studies tolerated the treatment well, experiencing mostly mild and temporary side effects, such as skin irritation at the electrode site. Additionally, research on similar spinal cord treatments found that 91% of participants reduced their asthma medication use by more than half. Notably, 73% stopped using medication entirely, indicating a positive impact on safety and effectiveness. These findings suggest that Pulmonary Neuromodulation could be a safe option for people with moderate to severe asthma.12345

Why are researchers excited about this trial?

Researchers are excited about pulmonary neuromodulation for asthma because it introduces a novel approach that targets the nervous system to manage asthma symptoms, unlike typical treatments that focus on reducing inflammation or opening airways. This method involves spinal cord stimulation, offering a new mechanism of action that may provide relief for patients who don't respond well to standard medications like inhaled corticosteroids or bronchodilators. By potentially altering nerve signals involved in asthma attacks, this treatment could offer a longer-lasting and more effective solution for managing asthma symptoms.

What evidence suggests that Pulmonary Neuromodulation might be an effective treatment for asthma?

Research has shown that Pulmonary Neuromodulation can greatly benefit people with moderate to severe asthma. One study found that 91% of participants reduced their asthma medication use by more than half. On average, patients experienced an 88% reduction in medication use. This trial will evaluate Pulmonary Neuromodulation through two different approaches: one group will receive immediate activation of the therapy, while another group will have delayed activation. Pulmonary Neuromodulation might reduce the need for traditional asthma drugs, potentially easing symptoms and improving quality of life. Some evidence also suggests it can help with airway tightening, a common issue in asthma.12367

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe asthma who are looking for new treatment options. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I have used biologic medicines for at least 6 months but my condition is still not controlled.
Subjects have a baseline AQLQ score less than 2.5
I am between 18 and 75 years old.
See 2 more

Exclusion Criteria

Uncontrolled diabetes (A1C >8% in last 3 months) or other medical conditions deemed exclusionary by Investigator
I have not needed antibiotics or steroids for a lung infection or asthma in the past 6 weeks.
Documented allergic response to titanium, platinum, polyurethane, epoxy, or silicone
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive full Spinal Cord Stimulation implant on Day 0. Therapy is activated immediately for the treatment arm and at Day 90 for the delayed activation arm. Safety and efficacy are assessed at multiple intervals.

6 months
Visits at 2 weeks, 1 month, 3 months, 4 months, 5 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pulmonary Neuromodulation

Trial Overview

The study is testing a procedure called spinal cord stimulation, which uses mild electrical signals to try and improve asthma symptoms. The main goal is to see if this method is safe and effective.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment armExperimental Treatment1 Intervention
Group II: Delayed activation armPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spiro Medical, Inc.

Lead Sponsor

Citations

Neuromodulation for the treatment of moderate to severe ...

91% of patients achieved a > 50% reduction in all asthma medication usage. For all patients enrolled there was an 88% reduction in all asthma medication use

Vagus nerve stimulation as a potential treatment for acute ...

Limited low-quality evidence suggests low-voltage VNS appears to reduce bronchoconstriction in both animal and human subjects. Improvement in ...

NCT07709754 | 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 Detailed

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40643323/

Neuromodulation for the treatment of moderate to severe ...

91% of patients achieved a > 50% reduction in all asthma medication usage. For all patients enrolled there was an 88% reduction in all asthma medication use and ...

Pulmonary rehabilitation yields long-term sustained ...

Immediate improvements were observed in asthma symptoms, pulmonary function, and quality of life post-rehabilitation. Patients were re-evaluated ...

Spinal cord stimulation shows promise as drug-free treatment ...

The results were striking: 91% of participants reduced their asthma medication use by more than 50%, and 73% eliminated medication use entirely ...

Electrical Neuromodulation of the Respiratory System After ...

The present review discusses the challenges and potentials of spinal cord stimulation for restoring respiratory function by overcoming some of ...