Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AlphaCore device
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
Eligibility Criteria
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
Sites / Locations
- Praxis fur Pneumologie am Asklepios Klinikum Uckermark
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active AlphaCore device
Sham AlphaCore device
Arm Description
AlphaCore active stimulation treatment
AlphaCore sham device
Outcomes
Primary Outcome Measures
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
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 Outcome Measures
Change in Borg Dyspnoea Scores
Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8
Change 6 Minutes Walking Test
Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups
Change in Forced Expiratory Volume (FEV1)
Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.
Change from baseline to week 8 between treatment groups
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)
The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.
Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index
Number of Subjects With Adverse Events (AE)
All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.
Brief description of the event (diagnosis)
Start date (and time, if relevant)
Stop date (and time, if relevant) (or resolution)
Severity
Action taken regarding the medical device
Opinion on causality
Seriousness
Outcome
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)
Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01679314
Brief Title
Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ElectroCore INC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active AlphaCore device
Arm Type
Active Comparator
Arm Description
AlphaCore active stimulation treatment
Arm Title
Sham AlphaCore device
Arm Type
Sham Comparator
Arm Description
AlphaCore sham device
Intervention Type
Device
Intervention Name(s)
AlphaCore device
Intervention Description
Each study group will go under the same treatment regimen and assessments.
Primary Outcome Measure Information:
Title
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Borg Dyspnoea Scores
Description
Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8
Time Frame
Baseline vs 8 weeks
Title
Change 6 Minutes Walking Test
Description
Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups
Time Frame
Baseline vs 8 weeks
Title
Change in Forced Expiratory Volume (FEV1)
Description
Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.
Change from baseline to week 8 between treatment groups
Time Frame
Baseline vs 8 weeks
Title
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)
Description
The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.
Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index
Time Frame
Baseline vs 8 weeks
Title
Number of Subjects With Adverse Events (AE)
Description
All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.
Brief description of the event (diagnosis)
Start date (and time, if relevant)
Stop date (and time, if relevant) (or resolution)
Severity
Action taken regarding the medical device
Opinion on causality
Seriousness
Outcome
Time Frame
Throughout the course of the study (baseline to the 4 month follow-up visit)
Title
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)
Description
Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state
Time Frame
Baseline vs 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias John, MD
Organizational Affiliation
Praxis für Pneumologie am Asklepios Klinikum Uckermark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Praxis fur Pneumologie am Asklepios Klinikum Uckermark
City
Schwedt
State/Province
Oder
ZIP/Postal Code
D-16303
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No description
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Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
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