Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device

Exclusion Criteria

• •1. Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
• •2. Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore™ treatment site.
• •3. Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
• •4. Has suspected or confirmed sepsis.
• •5. Has a clinically significant irregular heart rate or rhythm.
• •6. Has experienced recent clinically significant changes in blood pressure, has uncontrolled high blood pressure, or is presently receiving pressors to maintain blood pressure.
• •7. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
• •8. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
• •9. Has been implanted with metal cervical spine hardware.
• •10. Has a recent or repeated history of syncope.
• •11. Has a recent or repeated history of seizures.
• •12. Is pregnant or nursing, or of childbearing years and is unwilling to use an accepted form of birth control.
• •13. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
• •14. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
• •15. Is a relative of or an employee of the Investigator or the clinical study site.
• •2. Either (i) develops subjective symptoms of asthma (wheezing, shortness of breath, cough) for which the patient would normally self-medicate with a short acting beta agonist, and/or (ii) documents a drop of 20% from screening PEF scores as recorded in their patient diary.
• •3. At Visit 2, FEV1 is the same or lower than the screening FEV1 previously measured at visit 1 or the PEF is the same or lower than the screening previously measured at Visit 1.
• •1. The patient self-administered a short-acting beta agonist within 6 hours prior to onset of asthma symptoms.
• •2. The patient induced an asthma exacerbation by withholding their pre-treatment medication used for exercise-induced bronchoconstriction (EIB).
• •3. Has signs and symptoms of asthma instability at Visit 2:
• •* Lung Function: FEV1 \< 50 % predicted.
• •* Signs and symptoms of extreme respiratory distress at rest.
• •* Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc.).