Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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.
Interventions
DEVICEAlphaCore Device
multiple stimulation treatments per day for duration of hospitalization
Sponsors
ElectroCore INC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AlphaCore Active 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.
AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization | 2 |
| AlphaCore Sham Device AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.
AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | AlphaCore Sham Device | Total | AlphaCore Active Device |
|---|---|---|---|
| Age, Continuous | 72 years | 69 years | 66 years |
| Race/Ethnicity, Customized White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment Canada | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in the Length of Stay in the Hospital
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)
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
Population: Safety population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AlphaCore Active Device | Change in the Length of Stay in the Hospital | 9 Days |
| AlphaCore Sham Device | Change in the Length of Stay in the Hospital | 5.5 Days |