No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Spiro Medical, Inc. · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 75 with moderate to severe asthma that is not well controlled. Participants will assess a new treatment to see if it is safe and effective.
Are You a Good Fit for This Trial?
You may be able to join if
I have uncontrolled moderate to severe asthma for at least 1 year.
I am between 18 and 75 years old.
I have been on biologics for at least 6 months.
I have a baseline AQLQ score of less than 2.5.
My asthma treatment does not work well even with high-dose ICS-LABA.
You may not be able to join if
I have a BMI over 35.
I am a current smoker or have a significant smoking history.
I have other chronic lung diseases.
I need anticoagulant medications within 10 days of implantation.
I had a lower respiratory tract infection or asthma attack in the last 6 weeks.
I have significant heart disease or uncontrolled heart issues.
I have any medical condition that might interfere with the study.
I am pregnant or not using adequate contraception.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma
Trial Locations
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City
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Status
Eligibility Criteria
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 biol…
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
* Subjects have a baseline AQLQ of less than 2.5
* Subject is a surgical candidate with no contraindications for PNM implantation
Exclusion Criteria:
* 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%
* History of thoracic spine surgery and or spinal abnormalities, i.e., no more than 5 lumbar vertebrae, no scoliosis, or spinal deformities
* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain, etc.) or a medical condition that requires the subject to be treated with systemic opioids other than for post-surgical pain
* Any neurological condition that could interfere with normal lung function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
* Uncontrolled diabetes (A1C \> 8%, documented in the last three (3) months) or other medical condition determined by the Investigator that should be excluded
* Documented history of allergic response to titanium, platinum, polyurethane, epoxy, or silicone
* Planning to have diathermy, surgery requiring electrocautery, or high output ultrasonic exposure during the course of the study
* Any other implanted devices (e.g., drug delivery pumps, pacemaker, ICD) including neurostimulators whether turned on or off. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site, both the IPG or lead.
* A female with a positive urine pregnancy test or not using adequate contraception
* Currently participating in another treatment clinical trial
* Subject lacks capacity to consent for themselves
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