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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01679314
First received: August 15, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: AlphaCore device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Borg dyspnoea [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 6 minutes walking test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • FEV1 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • EQ5D [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the course of the study (baseline to the 4 month follow-up visit) ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active AlphaCore device
AlphaCore active stimulation treatment
Device: AlphaCore device
Each study group will go under the same treatment regimen and assessments.
Sham Comparator: Sham AlphaCore device
AlphaCore sham device
Device: AlphaCore device
Each study group will go under the same treatment regimen and assessments.

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679314

Locations
Germany
Praxis fur Pneumologie am Asklepios Klinikum Uckermark
Schwedt, Oder, Germany, D-16303
Sponsors and Collaborators
ElectroCore LLC
Investigators
Principal Investigator: Matthias John, MD Praxis für Pneumologie am Asklepios Klinikum Uckermark
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01679314     History of Changes
Other Study ID Numbers: AC-001
Study First Received: August 15, 2012
Last Updated: October 4, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by ElectroCore LLC:
COPD
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
non invasive
gammacore

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014