Pulmonary Neuromodulation for Asthma
(PULSAR Trial)
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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 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.
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
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 ...
5.
radboudumc.nl
radboudumc.nl/en/news-items/2023/pulmonary-rehabilitation-yields-long-term-sustained-improvements-in-asthmaPulmonary rehabilitation yields long-term sustained ...
Immediate improvements were observed in asthma symptoms, pulmonary function, and quality of life post-rehabilitation. Patients were re-evaluated ...
6.
ampulmonary.com
ampulmonary.com/asthma/article/22945873/spinal-cord-stimulation-shows-promise-as-drugfree-treatment-for-severe-asthmaSpinal 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 ...
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