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

NCT01679314 | Completed Results DMC

• 1 other identifier: AC-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; non invasive; gammacore

Outcome Measures

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

  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.

  8 weeks

Secondary Outcomes (6)

• Change in Borg Dyspnoea Scores

  Baseline vs 8 weeks

• Change 6 Minutes Walking Test

  Baseline vs 8 weeks

• Change in Forced Expiratory Volume (FEV1)

  Baseline vs 8 weeks

• Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)

  Baseline vs 8 weeks

• Number of Subjects With Adverse Events (AE)

  Throughout the course of the study (baseline to the 4 month follow-up visit)

Study Arms (2)

Active AlphaCore device

ACTIVE COMPARATOR

AlphaCore active stimulation treatment

Device: AlphaCore device

Sham AlphaCore device

SHAM COMPARATOR

AlphaCore sham device

Device: AlphaCore device

Interventions

AlphaCore device DEVICE

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

Active AlphaCore device; Sham AlphaCore device

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (1)

Praxis fur Pneumologie am Asklepios Klinikum Uckermark

Schwedt, Oder, D-16303, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Annelie Andersson
• Organization: electroCore LLC

annelie.andersson@electrocorellc.com

+46 721 803076

Study Officials

• Matthias John, MD

  Praxis für Pneumologie am Asklepios Klinikum Uckermark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: September 6, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 9, 2016
• Results First Posted: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)