RecruitingModerate to Severe Asthma

PULmonary Stimulation for Asthma Relief

Eligible age

18–75 yrs

Accepts

All genders

Locations

2 states

Healthy volunteers

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This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Sponsor: Spiro Medical, Inc.

✓ 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
✓ Subjects have a baseline AQLQ of less than 2.5
✓ Subject is a surgical candidate with no contraindications for PNM implantation

✕ BMI\> 35
✕ Current smokers or subjects with a significant smoking history (e.g., \>10 pack years for subjects less than 40 years of age and \>15 pack years for subjects 40 years and older) who have smoked within the last 6 months.
✕ Other chronic lung diseases including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), chronic bronchitis, vocal cord dysfunction, eosinophilic granulomatosis with polyangiitis (EGPA), history of lung cancer, or interstitial lung disease, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
✕ Requires continuous anticoagulant medications or taking alternative anticoagulant drugs or supplements within 10 days of implantation
✕ History of recurrent surgical infections (e.g. MRSA)
✕ In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, or systemic corticosteroids.
✕ Patients prescribed systemic corticosteroids for any condition, other than asthma, in the last 6 weeks. Subjects with asthma on oral corticosteroids taking more than 15mg/day.
✕ Significant coronary artery occlusive disease, angina, history of myocardial infarction and/or coronary artery stent(s), congestive heart failure, or uncontrolled cardiac arrythmias, cardiac stress test within the last 6 months with an Ejection Fraction of less than 45%

Denver

Gainseville

Source: ClinicalTrials.gov · NCT07709754 · last updated 2026-09-16