Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01612793
First received: May 25, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

This study will look at the safety, improving symptoms and decreasing the length of stay of patients admitted to the hospital with COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Device: AlphaCore Device
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Change in the Length of stay in the hospital [ Time Frame: Admission to hospital, 1 week in-person visit and a 30day phone call follow-up visit from time of discharge from the hosptil ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Complete CBC and blood gases will be drawn at different time points to establish the medical condition of the subjects.


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AlphaCore device
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
Device: AlphaCore Device
multiple stimulation treatments per day for duration of hospitalization
Other Name: Non-invasive vagus nerve stimulation

Detailed Description:

The primary safety measurement for this study is the type, occurrence and severity of adverse events (anticipated and unanticipated), including serious and non-serious device-related events.

The primary outcome measure is hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject meets the medical elements of the GOLD Discharge Criteria.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Potential study subjects will be provided a study information sheet (informed consent form) to review. Those who are interested in participating will provide signed informed consent and then be screened for eligibility (inclusion/exclusion criteria). Subjects meeting the inclusion/exclusion criteria will be assigned a study ID number, randomized and enrolled in the study.

Criteria

Inclusion Criteria:

  1. Is over the age of 35 years
  2. Has a history of COPD confirmed by physician diagnosis
  3. Has been admitted to the hospital with a working diagnosis of acute exacerbation of COPD (AECOPD) defined as at least two of the following progressive symptoms: increased dyspnea, increased sputum volume and/or increased sputum purulence that is beyond normal day-to-day variation
  4. Has a history of incomplete airway reversibility (e.g., patient not responding clinically to short-acting ß-agonists in the ED) associated with a diagnosis of COPD
  5. Smoking history of at least 20 pack years
  6. FEV1/FVC ratio of < 0.7 and impaired FEV1 (< 80% predicted for age, sex, race and height)
  7. Is willing to participate in a 7 days post discharge (± 2 days) in-person follow-up visit and a telephone follow-up call 30 days (± 5 days) after hospital discharge
  8. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent

Exclusion Criteria:

  1. Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms)
  2. Has a history of lung cancer or Talc lung
  3. Is admitted to the emergency care facility with a diagnosis of the following, confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT):

    • Pulmonary abscess;
    • Pneumonia (e.g., fever > 38.0° C, cough and new documented infiltrate)
    • Acute pulmonary embolism
    • Large pleural effusion and/or requiring thoracentesis; or
    • Pneumothorax
  4. Is admitted to the emergency care facility with a working diagnosis of:

    • Acute coronary syndrome
    • Severe carotid artery disease (e.g., history of bruits, transient ischemic attack (TIA) or cerebrovascular accident (CVA); or
    • Stage IV heart failure according to the NYHA classification
  5. Is admitted to the emergency care facility and/or hospital with a working diagnosis of:

    • Cystic Fibrosis; or
    • Tuberculosis
    • Pneumocystis carinii pneumonia (PCP) infection in the setting of HIV
  6. Other severe cardiovascular acute diseases (such as uncontrolled hypertension, recent onset rapid atrial fibrillation and severe ventricular arrhythmias)
  7. Is at risk of imminent respiratory collapse:

    • Lung Function: FEV1 < 25%
    • Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
  8. Has a condition in which collecting blood would be contraindicated or blood samples are unable to be obtained;
  9. Has an abscess or other infection, lesion (including lymphadenopathy), surgical scar, congenital changes or broken skin at the treatment site on the neck;
  10. Has confirmed severe sepsis or septic shock
  11. Has a fever > 38.0° C
  12. Has clinically significant changes in blood pressure or is receiving vasopressors to maintain blood pressure
  13. Has an implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, automated implantable cardioverter defibrillators (AICD), vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
  14. Has a history of carotid endarterectomy or vascular neck surgery on the right side
  15. Has implanted metal cervical spine hardware
  16. Has a condition that would interfere with completing the self-assessment questionnaires
  17. Is pregnant or breast feeding
  18. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
  19. Belongs to a population or has any condition such that the investigator believes 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)
  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: NCT01612793

Locations
Canada, Alberta
Edmonton Hospital
Edmonton, Alberta, Canada, T6G,2B7
Sponsors and Collaborators
ElectroCore LLC
Investigators
Principal Investigator: Brian Rowe, M.D. University of Alberta
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01612793     History of Changes
Other Study ID Numbers: COPD-CA-01
Study First Received: May 25, 2012
Last Updated: January 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by ElectroCore LLC:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014