Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of EIB

NCT01923272 | Withdrawn

• 1 other identifier: BC-US-07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect additional preliminary clinical data related to the safety and clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction, and to support the development and approval of a larger pivotal study. The objectives of this study are (1) to gather preliminary safety and efficacy data of the AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an effective control for use in future clinical studies, and (3) to support the development and approval of a pivotal study, confirm data collection methods and endpoint definitions, and confirm appropriateness of the subject follow up plan.

Conditions

Asthma

Study Arms (2)

Sham Device

SHAM COMPARATOR

inactive AlphaCore device

Device: AlphaCore Device; Device: AlphaCore

AlphaCore

ACTIVE COMPARATOR

Active AlphaCore device

Device: AlphaCore Device; Device: AlphaCore

Interventions

AlphaCore Device DEVICE

Active stimulation to the vagal nerve

AlphaCore; Sham Device

AlphaCore DEVICE

Active AlphaCore treatment

AlphaCore; Sham Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is able to give written Informed Consent.
• Is between the ages of 18 and 60 years, male or female.
• Has a history of breathlessness during and after exertion.
• Normally controls or prevents EIB using a short acting beta-agonist (SABA).
• Is willing to take a urine pregnancy test if female of childbearing potential and agrees not to become pregnant for the duration of the study.

You may not qualify if:

• Has any condition that would prevent or otherwise inhibit reasonable exertion required to induce bronchoconstriction.
• Is unable to perform acceptable-quality spirometry (FEV1 \< 75% predicted).
• Is currently using Beta2-adrenergic blockers (i.e. propranolol).
• Has smoked within the past year, and/or more than 10 pack year history.
• Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
• Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore treatment site.
• Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA).
• Has a clinically significant irregular heart rate or rhythm.
• Has uncontrolled hypertension (systolic bp \> 200 or diastolic bp \>100), recent (within the last 3 months) heart attack, recent (within the last 3 months) stroke, known aortic aneurysm, or congestive heart failure (CHF).
• 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.
• Has a history of carotid endarterectomy, vagotomy (right or bilateral), dysaesthesia or vascular neck surgery on the right side.
• Has been implanted with metal cervical spine hardware.
• Has a recent or repeated history of syncope.
• Has a recent or repeated history of seizures.
• Has a condition that would interfere with VAS Dyspnea self-assessment.

Sponsors & Collaborators

• ElectroCore INC: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Peter Weiman

  ElectroCore INC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: August 15, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 15, 2013

Record last verified: 2013-08