Clinical trial NCT01679314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
non invasive
gammacore
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Borg Dyspnoea Scores
timeFrame: Baseline vs 8 weeks
measure: Change 6 Minutes Walking Test
timeFrame: Baseline vs 8 weeks
measure: Change in Forced Expiratory Volume (FEV1)
timeFrame: Baseline vs 8 weeks
measure: Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)
timeFrame: Baseline vs 8 weeks
measure: Number of Subjects With Adverse Events (AE)
timeFrame: Throughout the course of the study (baseline to the 4 month follow-up visit)
measure: Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)
timeFrame: Baseline vs 8 weeks
Other outcomes:
Locations:
city: Schwedt
country: Germany
facility: Praxis fur Pneumologie am Asklepios Klinikum Uckermark
state: Oder
Study officials:
affiliation: Praxis für Pneumologie am Asklepios Klinikum Uckermark
name: Matthias John, MD
role: PRINCIPAL_INVESTIGATOR
References: