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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01679314
Recruitment Status : Completed
First Posted : September 6, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):
ElectroCore INC

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: AlphaCore device Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Borg Dyspnoea Scores [ Time Frame: Baseline vs 8 weeks ]
    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

  2. Change 6 Minutes Walking Test [ Time Frame: Baseline vs 8 weeks ]
    Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups

  3. Change in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline vs 8 weeks ]

    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

  4. Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) [ Time Frame: Baseline vs 8 weeks ]

    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

  5. Number of Subjects With Adverse Events (AE) [ Time Frame: Throughout the course of the study (baseline to the 4 month follow-up visit) ]

    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

  6. Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) [ Time Frame: Baseline vs 8 weeks ]
    Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01679314

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Praxis fur Pneumologie am Asklepios Klinikum Uckermark
Schwedt, Oder, Germany, D-16303
Sponsors and Collaborators
ElectroCore INC
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Principal Investigator: Matthias John, MD Praxis für Pneumologie am Asklepios Klinikum Uckermark
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Responsible Party: ElectroCore INC Identifier: NCT01679314    
Other Study ID Numbers: AC-001
First Posted: September 6, 2012    Key Record Dates
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No description
Keywords provided by ElectroCore INC:
vagus nerve stimulation
vagal nerve stimulation
non invasive
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases