PULmonary Stimulation for Asthma Relief
ConditionModerate to Severe Asthma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Spinal Cord Stimulation
DeviceImplantation of a Spinal Cord Stimulation system
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Treatment armExperimental treatment 1 intervention
Group B: Delayed activation armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
ACT score
Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score \>19
Time frame
3 monthsSecondary outcomes
1
Asthma related Quality of Life Questionnaire (AQLQ)
Proportion of subjects within each group who achieve a clinically meaningful improvement in AQLQ
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov