AsthmaNCT01923272
Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of EIB
A study testing AlphaCore Device and AlphaCore in people with Asthma, run by ElectroCore INC.
Trial summary
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect additional preliminary clinical data related to the safety and clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore device for the treatment and prevention of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- AlphaCore Device and AlphaCore
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is able to give written Informed Consent.
- Is between the ages of 18 and 60 years, male or female.
- Has a history of breathlessness during and after exertion.
- Normally controls or prevents EIB using a short acting beta-agonist (SABA).
- Is willing to take a urine pregnancy test if female of childbearing potential and agrees not to become pregnant for the duration of the study.
Who cannot join
- Has any condition that would prevent or otherwise inhibit reasonable exertion required to induce bronchoconstriction.
- Is unable to perform acceptable-quality spirometry (FEV1 < 75% predicted).
- Is currently using Beta2-adrenergic blockers (i.e. propranolol).
- Has smoked within the past year, and/or more than 10 pack year history.
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
- Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore treatment site.
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- Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA).
- Has a clinically significant irregular heart rate or rhythm.
- Has uncontrolled hypertension (systolic bp > 200 or diastolic bp >100), recent (within the last 3 months) heart attack, recent (within the last 3 months) stroke, known aortic aneurysm, or congestive heart failure (CHF).
- 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, vagotomy (right or bilateral), dysaesthesia or vascular neck surgery on the right side.
- Has been implanted with metal cervical spine hardware.
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizures.
- Has a condition that would interfere with VAS Dyspnea self-assessment.
- Is pregnant or nursing, or of childbearing potential and is unwilling to use an accepted form of birth control.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
- Is an employee or relative of the Investigator or the clinical study site.
About this study
Official title: Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of Exercised Induced Bronchoconstriction
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect additional preliminary clinical data related to the safety and clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction, and to support the development and approval of a larger pivotal study.
The objectives of this study are (1) to gather preliminary safety and efficacy data of the AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an effective control for use in future clinical studies, and (3) to support the development and approval of a pivotal study, confirm data collection methods and endpoint definitions, and confirm appropriateness of the subject follow up plan.
Read the detailed description
Study Design Summary Study Type: Prospective, randomized (allocated 1:1), double-blind, sham-controlled pilot study Sample Size: Up to 60 subjects Number of Sites: Up to 10 sites Anticipated Study Duration: 8 months
Number of Study Visits: Three:
- Screening Visit
- Treatment Visit 1 - treatment with AlphaCore (active or sham) after exercise challenge
- Treatment Visit 2 - Prophylactic treatment with AlphaCore (active or sham) prior to exercise challenge
There will be a telephone follow-up call within 12-24 hours after the treatment visits occur as well as a 7-day (+/- 3 days) final phone call after Treatment Visit 2.
# of Study Arm(s): Two Arms
- Active Treatment with the AlphaCore Device
- Sham Treatment with an inactive sham device Blinding Double blind. The subject will be blinded to treatment assignment. Due to the treating Investigator's or designee designee's ability to detect differences in muscle effects between the active and sham device, the treating Investigator or designee cannot be blinded. Data assessors will be blinded.
- Conditions
- Asthma
- Being tested
- AlphaCore Device, AlphaCore
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaCore DeviceDevice
Active stimulation to the vagal nerve
AlphaCoreDevice
Active AlphaCore treatment
| Study group | Role | What they receive |
|---|---|---|
| Sham Device | Sham comparator | inactive AlphaCore device Receives: Device: AlphaCore Device; Device: AlphaCore |
| AlphaCore | Active comparator | Active AlphaCore device Receives: Device: AlphaCore Device; Device: AlphaCore |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Similar study being conducted, Sponsor decided to not duplicate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Weiman, Study director, ElectroCore INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923272
- Sponsor's protocol ID
- BC-US-07
- Status last verified
- Aug 2013
- First submitted
- 5 Jun 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of Exercised Induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT01923272
- Acronym / sponsor ID
- BC-US-07
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar study being conducted, Sponsor decided to not duplicate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect additional preliminary clinical data related to the safety and clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction, and to support the development and approval of a larger pivotal study.
The objectives of this study are (1) to gather preliminary safety and efficacy data of the AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an effective control for use in future clinical studies, and (3) to support the development and approval of a pivotal study, confirm data collection methods and endpoint definitions, and confirm appropriateness of the subject follow up plan.
Detailed description
Study Design Summary Study Type: Prospective, randomized (allocated 1:1), double-blind, sham-controlled pilot study Sample Size: Up to 60 subjects Number of Sites: Up to 10 sites Anticipated Study Duration: 8 months
Number of Study Visits: Three:
- Screening Visit
- Treatment Visit 1 - treatment with AlphaCore (active or sham) after exercise challenge
- Treatment Visit 2 - Prophylactic treatment with AlphaCore (active or sham) prior to exercise challenge
There will be a telephone follow-up call within 12-24 hours after the treatment visits occur as well as a 7-day (+/- 3 days) final phone call after Treatment Visit 2.
# of Study Arm(s): Two Arms
- Active Treatment with the AlphaCore Device
- Sham Treatment with an inactive sham device Blinding Double blind. The subject will be blinded to treatment assignment. Due to the treating Investigator's or designee designee's ability to detect differences in muscle effects between the active and sham device, the treating Investigator or designee cannot be blinded. Data assessors will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Device | Sham comparator | Device: AlphaCore Device, Device: AlphaCoreinactive AlphaCore device |
| AlphaCore | Active comparator | Device: AlphaCore Device, Device: AlphaCoreActive AlphaCore device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is able to give written Informed Consent.
- Is between the ages of 18 and 60 years, male or female.
- Has a history of breathlessness during and after exertion.
- Normally controls or prevents EIB using a short acting beta-agonist (SABA).
- Is willing to take a urine pregnancy test if female of childbearing potential and agrees not to become pregnant for the duration of the study.
Key exclusion criteria (19 listed)
- Has any condition that would prevent or otherwise inhibit reasonable exertion required to induce bronchoconstriction.
- Is unable to perform acceptable-quality spirometry (FEV1 < 75% predicted).
- Is currently using Beta2-adrenergic blockers (i.e. propranolol).
- Has smoked within the past year, and/or more than 10 pack year history.
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
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 DeviceActive stimulation to the vagal nerve | Device | AlphaCore, Sham Device |
| AlphaCoreActive AlphaCore treatment | Device | AlphaCore, Sham Device |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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.
Peter Weiman study director
ElectroCore INC
Questions about this trial
What is this clinical trial studying?
A study testing AlphaCore Device and AlphaCore in people with Asthma, run by ElectroCore INC.
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 19 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: withdrawn, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 15 Aug 2013.