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

Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma

The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma.

Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.

Subjects will be screened, consented and enrolled at the first visit. Subjects will return to the second visit where they are experiencing shortness of breath and will be treated with the alphacore. Breathing and vital signs will be measured before, during and after the stimulation. The study is concluded on the third visit, 7 days later.

INCLUSION CRITERIA: VISIT 1

1. Is able to give written Informed Consent.
2. Is between the ages of 18 and 65 years, male or female.
3. Has a known history of mild to moderate asthma for at least 1 year as defined by GINA Guidelines.
4. Is using a short acting beta-agonist for relief/rescue of asthma..
5. At Visit 1, demonstrates current or historical (within 1 year) FEV1 reversibility of at least 12% (and 200ml) or greater within 15-30 minutes following administration of 4 inhalations of albuterol.

EXCLUSION CRITERIA: VISIT 1

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.

INCLUSION CRITERIA: VISIT 2

1. No changes have occurred in the patient's health or status relative to the original inclusion and exclusion criteria and the patient continues to be eligible for participation in the study.
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.

EXCLUSION CRITERIA: VISIT 2

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.).