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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679314
• Other study ID #: AC-001
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: October 4, 2013
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2013
• Source: ElectroCore LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• AlphaCore device
Each study group will go under the same treatment regimen and assessments.

Locations

Country	Name	City	State
Germany	Praxis fur Pneumologie am Asklepios Klinikum Uckermark	Schwedt	Oder

Sponsors (1)

Lead Sponsor	Collaborator
ElectroCore LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Borg dyspnoea		8 weeks	No
Secondary	6 minutes walking test		8 weeks	No
Secondary	FEV1		8 weeks	No
Secondary	EQ5D		8 weeks	No
Secondary	Adverse events		Throughout the course of the study (baseline to the 4 month follow-up visit)	Yes