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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: AlphaCore device

• Registration Number: NCT01679314
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-06
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Results First Submitted: 2015-01-16
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Results First Posted: 2016-05-09
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active AlphaCore device	AlphaCore device	AlphaCore active stimulation treatment
Sham AlphaCore device	AlphaCore device	AlphaCore sham device

Primary Outcome Measures

Name	Time	Method
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups	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

Name	Time	Method
Change in Forced Expiratory Volume (FEV1)	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
Number of Subjects With Adverse Events (AE)	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
Change 6 Minutes Walking Test	Baseline vs 8 weeks	Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups
Change in Borg Dyspnoea Scores	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
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)	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
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)	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

Trial Locations

Locations (1)

Praxis fur Pneumologie am Asklepios Klinikum Uckermark; 🇩🇪 Schwedt, Oder, Germany