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

NCT01612793 | Terminated Results DMC

• 1 other identifier: COPD-CA-01
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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)

  Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal

Study Arms (1)

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

Interventions

AlphaCore Device DEVICE

multiple stimulation treatments per day for duration of hospitalization

Also known as: Non-invasive vagus nerve stimulation

AlphaCore device

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Is over the age of 35 years
• Has a history of COPD confirmed by physician diagnosis
• 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
• 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
• Smoking history of at least 20 pack years
• FEV1/FVC ratio of \< 0.7 and impaired FEV1 (\< 80% predicted for age, sex, race and height)
• 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
• Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent

You may not qualify if:

• Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms)
• Has a history of lung cancer or Talc lung
• 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
• 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
• Is admitted to the emergency care facility and/or hospital with a working diagnosis of:
• Cystic Fibrosis; or
• Tuberculosis

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (1)

Edmonton Hospital

Edmonton, Alberta, T6G,2B7, Canada

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs
• Organization: electroCore LLC

clinical@electrocorellc.com

+1 973 355 6683

Study Officials

• Brian Rowe, M.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 6, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2018-03

Locations

CA (1)