RecruitingNot applicable

PULmonary Stimulation for Asthma Relief

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study is expected to complete enrollment in approximately 3 months and follow the patients per protocol for 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe pulmonary neuromodulation is and how well it works for asthma. This treatment uses an implanted device to stimulate nerves. It is for adults with moderate to severe asthma that is not well controlled despite treatment.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • An allergy or lung specialist diagnosed your moderate to severe asthma at least 1 year before study group assignment.
  • Your asthma is poorly controlled despite high-dose inhaled steroid and long-acting airway-opening medicine, biologic medicines, or both. Your Asthma Control Test (ACT) score is 15 or lower.
  • You have used biologic medicines—medicines that target parts of the immune system—for at least 6 months, now or in the past, and your asthma remains uncontrolled.
  • Your Asthma Quality of Life Questionnaire (AQLQ) score is below 2.5.
  • You can safely have surgery to place the study device.

Who can't join

  • Your body mass index (BMI), a measure based on height and weight, is above 35. You currently smoke, or you have a substantial smoking history and smoked within the last 6 months.
  • You have another long-term lung disease, a history of lung cancer, or a chest or spine problem that affects breathing. Certain spine problems or past upper or middle back spine surgery also exclude you.
  • You need ongoing blood thinners, used other blood-thinning drugs or supplements within 10 days before implantation, or have repeated infections after surgery. You have a known allergy to titanium, platinum, polyurethane, epoxy, or silicone.
  • In the past 6 weeks, you had a lung infection or asthma flare needing antibiotics or steroids that treat the whole body, or were prescribed these steroids for a condition other than asthma. You take more than 15 mg of oral steroids daily for asthma.
  • You have serious heart disease, uncontrolled heart rhythm problems, certain nerve or brain conditions that may affect breathing, or uncontrolled diabetes with an A1C above 8%. Other health problems that affect the study, or a need for opioid medicines other than for pain after surgery, may also exclude you.
  • You have another implanted device, even if turned off. Passive implants, such as artificial joints, are allowed, but metal cannot be at the study device or wire sites. Planned deep-heat treatment, surgery using electric current, or high-output ultrasound also excludes you.
  • You have a positive urine pregnancy test or are female and are not using adequate birth control.
  • You are in another treatment study or cannot give consent for yourself.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (3)

CO

  • National Jewish Health · Denver, CO 80206Michael E Wechsler, MD · Principal investigatorMore trials in Denver

FL