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
Spiro Medical, Inc.
Summary
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DeviceSpinal Cord Stimulation
Implantation of a Spinal Cord Stimulation system
Locations (2)
- National Jewish HealthDenver, Colorado
- University of FloridaGainesville, Florida