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

NCT ID: NCT01679314

Last Updated: 2016-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active AlphaCore device

AlphaCore active stimulation treatment

Group Type: ACTIVE_COMPARATOR

AlphaCore device

Intervention Type: DEVICE

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

Sham AlphaCore device

AlphaCore sham device

Group Type: SHAM_COMPARATOR

AlphaCore device

Intervention Type: DEVICE

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

Interventions

AlphaCore device

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElectroCore INC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias John, MD

Role: PRINCIPAL_INVESTIGATOR

Praxis für Pneumologie am Asklepios Klinikum Uckermark

Locations

Praxis fur Pneumologie am Asklepios Klinikum Uckermark

Schwedt, Oder, Germany

Countries

Germany

Other Identifiers

AC-001

Identifier Type: -

Identifier Source: org_study_id