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OpenTrials
Completed

NCT Number: NCT01679314

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Praxis fur Pneumologie am Asklepios Klinikum Uckermark

Schwedt, Oder, D-16303, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AlphaCore device

Device

Each study group will go under the same treatment regimen and assessments.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ElectroCore INC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2012
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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