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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612793
Recruitment Status : Terminated
First Posted : June 6, 2012
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Information provided by (Responsible Party):
ElectroCore INC

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

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: AlphaCore Device

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.

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Study Type : Observational
Actual Enrollment : 4 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Change in the Length of Stay in the Hospital [ Time Frame: Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal ]
    The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)

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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612793

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Canada, Alberta
Edmonton Hospital
Edmonton, Alberta, Canada, T6G,2B7
Sponsors and Collaborators
ElectroCore INC
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Principal Investigator: Brian Rowe, M.D. University of Alberta

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Responsible Party: ElectroCore INC Identifier: NCT01612793     History of Changes
Other Study ID Numbers: COPD-CA-01
First Posted: June 6, 2012    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: March 2018

Keywords provided by ElectroCore INC:

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