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

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01679314

Enrollment

Registered

2012-09-06

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

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.

Interventions

DEVICEAlphaCore device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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
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
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 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

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Active AlphaCore Device AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	26
Sham AlphaCore Device AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.	28
Total	54

Baseline characteristics

Characteristic	Active AlphaCore Device	Sham AlphaCore Device	Total
Age, Continuous	61.2 years STANDARD_DEVIATION 7.2	58.0 years STANDARD_DEVIATION 7.6	59.5 years STANDARD_DEVIATION 7.5
Region of Enrollment Germany	26 participants	28 participants	54 participants
Sex: Female, Male Female	9 Participants	12 Participants	21 Participants
Sex: Female, Male Male	17 Participants	16 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / 26	3 / 28
serious Total, serious adverse events	3 / 26	1 / 28

Outcome results

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

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.

Time frame: 8 weeks

Population: One patient in the Active AlphaCore device Group missing data at 8 weeks.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Active AlphaCore Device	Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups	-1.3 units on a scale
Sham AlphaCore Device	Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups	-0.9 units on a scale

Secondary

Change 6 Minutes Walking Test

Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups