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

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: AlphaCore Device

• Registration Number: NCT01612793
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Study Start: 2012-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2018-03
• Results First Submitted: 2018-03-27
• Results First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-25
• Results First Posted: 2019-02-28
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AlphaCore device	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.

Primary Outcome Measures

Name	Time	Method
Change in the Length of Stay in the Hospital	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)

Trial Locations

Locations (1)

Edmonton Hospital; 🇨🇦 Edmonton, Alberta, Canada