Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01679314
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2012-08-15
Brief Title:
Study to Compare COPD Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
Sponsor:
ElectroCore INC
Organization:
ElectroCore INC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None