Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment

Launched by ELECTROCORE INC · Aug 31, 2012

Keywords

ClinConnect Summary

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 th...

Gender

ALL

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