A Prospective, Single Site, Randomized, Controlled, Parallel Group Study in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Stage III and IV Using AlphaCore or Sham (Control, Not Active) as a Prophylactic Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ElectroCore INC
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
Study Overview
Brief Summary
The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham device during these two months while not knowing which device they have been provided. At the end of the two months, all patients will be asked to continue in the study for another 2 months to self administer with the active AlphaCore device. Subjects will complete diaries at home on their breathing and quality of life and will return to the clinic monthly for assessment by the investigator.
Detailed Description
PERFORMANCE AND SAFETY VARIABLES:
The primary efficacy endpoint for this study is the total Chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) score change from baseline to the 8 week follow-up period comparing the two device groups.
Secondary efficacy endpoints will be the mean difference from baseline to the 8 week follow-up for the following assessments: Medical Research Council (MRC) dyspnoea scale, 6 minutes walking test and Forced Expiratory Volume in one second (FEV1)
Safety Variables:
Each subject will be assessed throughout the study for Adverse Events and at the last visit (4 months) subjects will undergo another physical examination including vital signs and blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 40-75 years
- •Diagnosed Chronic obstructive pulmonary disease(COPD) stage III and IV according to Global Initiative for chronic obstructive lung disease (GOLD) guideline
- •Forced expiratory volume in one second (FEV 1) < 50%
- •Forced expiratory volume in one second (FEV1/Forced expiratory vital capacity (FVC) < 70%
- •Signed informed consent form
Exclusion Criteria
- •Participation in other clinical trials (drug or medical device) 30 days prior to start of this study
- •Subject is unable to comply with the procedures if the protocol for the study or any other reason judged by the Investigator that could interfere with the study assessment or follow-up
- •Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore® treatment site.
- •Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- •Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- •Right side or bilateral vagotomy
- •Has a recent or repeated history of syncope.
- •Has a recent or repeated history of seizures.
- •Pregnant or breast feeding women
Outcomes
Primary Outcomes
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
Time Frame: 8 weeks
Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.
Secondary Outcomes
- Change in Forced Expiratory Volume (FEV1)(Baseline vs 8 weeks)
- Number of Subjects With Adverse Events (AE)(Throughout the course of the study (baseline to the 4 month follow-up visit))
- Change 6 Minutes Walking Test(Baseline vs 8 weeks)
- Change in Borg Dyspnoea Scores(Baseline vs 8 weeks)
- Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)(Baseline vs 8 weeks)
- Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)(Baseline vs 8 weeks)