Chronic Obstructive Pulmonary DiseaseNCT01679314
Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
A study testing AlphaCore device in people with Chronic Obstructive Pulmonary Disease, run by ElectroCore INC at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AlphaCore device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizures.
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Praxis fur Pneumologie am Asklepios Klinikum Uckermark
Schwedt, Oder, D-16303
About this study
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
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.
Read the 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
- Being tested
- AlphaCore device
- Keywords
- COPD, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaCore deviceDevice
Each study group will go under the same treatment regimen and assessments.
| Study group | Role | What they receive |
|---|---|---|
| Active AlphaCore device | Active comparator | AlphaCore active stimulation treatment Receives: Device: AlphaCore device |
| Sham AlphaCore device | Sham comparator | AlphaCore sham device Receives: Device: AlphaCore device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
Change in Borg Dyspnoea Scores
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
Measured: Baseline vs 8 weeks
Change 6 Minutes Walking Test
Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups
Measured: Baseline vs 8 weeks
Change in Forced Expiratory Volume (FEV1)
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
Measured: Baseline vs 8 weeks
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)
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
Measured: Baseline vs 8 weeks
Number of Subjects With Adverse Events (AE)
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
Measured: Throughout the course of the study (baseline to the 4 month follow-up visit)
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)
Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state
Measured: Baseline vs 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias John, MD, Principal investigator, Praxis für Pneumologie am Asklepios Klinikum Uckermark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679314
- Sponsor's protocol ID
- AC-001
- Status last verified
- May 2016
- First submitted
- 15 Aug 2012
- Last updated
- 9 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No description
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01679314
- Acronym / sponsor ID
- AC-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Posted 9 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active AlphaCore device | Active comparator | Device: AlphaCore deviceAlphaCore active stimulation treatment |
| Sham AlphaCore device | Sham comparator | Device: AlphaCore deviceAlphaCore sham device |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlphaCore deviceEach study group will go under the same treatment regimen and assessments. | Device | Active AlphaCore device, Sham AlphaCore device |
Primary outcome
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
Time frame: 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.
6 secondary outcomes
Change in Borg Dyspnoea Scores
Time frame: Baseline vs 8 weeks
Change 6 Minutes Walking Test
Time frame: Baseline vs 8 weeks
Change in Forced Expiratory Volume (FEV1)
Time frame: Baseline vs 8 weeks
Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)
Time frame: Baseline vs 8 weeks
Number of Subjects With Adverse Events (AE)
Time frame: Throughout the course of the study (baseline to the 4 month follow-up visit)
Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)
Time frame: Baseline vs 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No description
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias John, MD principal investigator
Praxis für Pneumologie am Asklepios Klinikum Uckermark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlphaCore device in people with Chronic Obstructive Pulmonary Disease, run by ElectroCore INC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.