Trial Outcomes & Findings for Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment (NCT NCT01679314)

NCT ID: NCT01679314

Last Updated: 2016-05-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-05-09

Participant Flow

Participant milestones

Measure	Active AlphaCore Device AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Overall Study STARTED	26	28
Overall Study COMPLETED	24	28
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Active AlphaCore Device n=26 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Total n=54 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 7.2 • n=5 Participants	58.0 years STANDARD_DEVIATION 7.6 • n=7 Participants	59.5 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Germany	26 participants n=5 Participants	28 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
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 Interval -3.2 to 0.6	-0.9 units on a scale Interval -2.7 to 0.8

SECONDARY outcome

Timeframe: Baseline vs 8 weeks

Population: One subject in the Active AlphaCore device Group missing data at 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

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Change in Borg Dyspnoea Scores	0.7 Scores on a scale Standard Deviation 2.0	0.4 Scores on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline vs 8 weeks

Population: One patient in the Active AlphaCore group is missing data at week 8

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

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Change 6 Minutes Walking Test	8.1 Meter Standard Deviation 61.5	12.6 Meter Standard Deviation 55.2

SECONDARY outcome

Timeframe: Baseline vs 8 weeks

Population: One subject in the Active AlphaCore group missing data at week 8

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

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Change in Forced Expiratory Volume (FEV1) Baseline	30.7 Percentage of predicted value Standard Deviation 8.8	29.7 Percentage of predicted value Standard Deviation 8.0
Change in Forced Expiratory Volume (FEV1) Week 8	31.0 Percentage of predicted value Standard Deviation 9.5	31.0 Percentage of predicted value Standard Deviation 9.1

SECONDARY outcome

Timeframe: Baseline vs 8 weeks

Population: One patient in the Active AlphaCore group is missing data at 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

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Mobility-no problem baseline	7 participants	6 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Mobility-no problem week 8	8 participants	7 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Self Care-no problem baseline	17 participants	21 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Self Care-no problem week 8	17 participants	22 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Daily Activiies-no problem baseline	6 participants	9 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Daily Activies- no problem week 8	4 participants	7 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Pain-no problem baseline	12 participants	19 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Pain-no problem week 8	15 participants	22 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Anxiety-no problem baseline	12 participants	13 participants
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) Anxiety-no problem week 8	14 participants	17 participants

SECONDARY outcome

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

Population: All subjects reporting any Adverse Event

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

Outcome measures

Measure	Active AlphaCore Device n=26 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Number of Subjects With Adverse Events (AE)	10 participants	6 participants

SECONDARY outcome

Timeframe: Baseline vs 8 weeks

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

Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state

Outcome measures

Measure	Active AlphaCore Device n=25 Participants AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 Participants AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) 8 weeks	52.8 units on a scale Standard Deviation 18.3	55.7 units on a scale Standard Deviation 20.0
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) Baseline	53.3 units on a scale Standard Deviation 20.0	51.6 units on a scale Standard Deviation 16.9

Adverse Events

Active AlphaCore Device

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham AlphaCore Device

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active AlphaCore Device n=26 participants at risk AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 participants at risk AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Respiratory, thoracic and mediastinal disorders Acute COPD exacebartion	3.8% 1/26 • Number of events 1 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	0.00% 0/28 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label
Vascular disorders Cartoid stenosis left	3.8% 1/26 • Number of events 1 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	0.00% 0/28 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 1/26 • Number of events 1 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	0.00% 0/28 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label
Respiratory, thoracic and mediastinal disorders Bronchopneumonia both sides	0.00% 0/26 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	3.6% 1/28 • Number of events 1 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label

Other adverse events

Measure	Active AlphaCore Device n=26 participants at risk AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments.	Sham AlphaCore Device n=28 participants at risk AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments.
Respiratory, thoracic and mediastinal disorders Common cold	7.7% 2/26 • Number of events 2 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	7.1% 2/28 • Number of events 2 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label
Respiratory, thoracic and mediastinal disorders Infection of the respiratory tract	7.7% 2/26 • Number of events 2 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label	3.6% 1/28 • Number of events 1 • 16 weeks The first 8 weeks randomized controlled, the last 8 weeks open label

Additional Information

Annelie Andersson

electroCore LLC

Phone: +46 721 803076

Email: annelie.andersson@electrocorellc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place