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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01532817
First received: February 10, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Bronchoconstriction
Asthma
Device: The AlphaCore Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Safety- type and occurrence of adverse events, including device-related, serious or unanticipated [ Time Frame: From time subject signs the consent through the 1-week follow-up visit ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: The AlphaCore Device
    A single 90 second stimulation to the vagus nerve on the right side of the neck
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532817

Locations
United States, California
Allergy and Asthma
San Diego, California, United States
United States, Minnesota
CRI
Minneapolis, Minnesota, United States
United States, Oklahoma
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Sponsors and Collaborators
ElectroCore LLC
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01532817     History of Changes
Other Study ID Numbers: BC-US-06
Study First Received: February 10, 2012
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014