Clinical trial NCT01612793: Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
Official title: Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 4
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Change in the Length of Stay in the Hospital
timeFrame: Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Brian Rowe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: