PULmonary Stimulation for Asthma Relief
ConditionModerate to Severe Asthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSpiro Medical, Inc.
About this trial
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma
Eligibility criteria
Qualifiers
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
Disqualifiers
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
BMI> 35
Trial design
Treatments tested in this trial
- Spinal Cord Stimulation
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov