AsthmaBC-SA-01NCT01385306
Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma
A study testing AlphaCore System in people with Asthma, run by ElectroCore INC at 5 sites in South Africa.
Trial summary
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- AlphaCore System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesSouth Africa
- Study dates
- Jun 2011to Jul 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is between the ages of 18 and 70 years.
- Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
- Has an FEV1<60% predicted.
- Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED.
- Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
Who cannot join
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
- Is at risk of imminent respiratory collapse:
- Lung Function: FEV1 < 25% predicted
- Signs and symptoms of extreme respiratory distress at rest, such as accessory muscle use, chest retraction
- Consciousness State: Drowsy, confused
- Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
Show all 18Show fewer
- Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
- Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has suspected or confirmed sepsis.
- Has a clinically significant irregular heart rate or rhythm.
- Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure.
- Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, 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.
- Has been implanted with metal cervical spine hardware.
- Has a condition that would interfere with VAS Dyspnea self-assessment.
- Is pregnant.
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Africa5 sites
Christiaan Barnard Memorial Hospital
Cape Town, 8001
Kuilsriver Hospital
Kuils River, Cape Town, 7580
Panorama Mediclinic
Panorama, Cape Town, 7500
Life Vincent Pallotti Hospital
Pinelands, Cape Town, 7405
Cape Gate Medi-Clinic Hospital
Stellenbosch, Cape Town, 7600
About this study
Official title: Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.
Read the detailed description
The purpose of the study was to collect initial safety and efficacy information of use of the AlphaCore System by clinicians in an emergency setting as an adjunctive treatment to standard of care for the relief of acute bronchoconstriction. After consent was obtained and screening completed, subjects were stimulated two times, 30 minutes apart, for 90 seconds each. Subjects were assessed prior to and immediately post the first stimulation and at 15, 30, 60, and 90 minutes; follow was also conducted at day 7 and day 30.
- Conditions
- Asthma
- Being tested
- AlphaCore System
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaCore SystemDevice
Non-invasive neurostimulation of the vagus nerve
| Study group | Role | What they receive |
|---|---|---|
| AlphaCore System | Experimental | non-invasive vagus nerve stimulation (nVNS) using the AlphaCore System Receives: Device: AlphaCore System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.
Measured: 30 days
Secondary outcomes (4)
Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes
Improvement in FEV1 was defined as an increase of at least 12% compared with baseline (pre-first stimulation). The 30 minute measure was taken immediately after the second stimulation.
(FEV1 measured as a percentage of normal, where greater that 80% is normal and less than 40% is severe degree of obstruction.)
Measured: 30 minutes
Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes
Improvement in dyspnea was defined as at least 1.5 point decrease on a 10 point Visual Analogue Scale (VAS) compared with baseline (pre-first stimulation). Where 0 = no dyspnea and 10 = very severe dyspnea. The 30 minute measure was taken immediately after the second stimulation.
Measured: 30 minutes
Time to Discharge From the Emergency Department
Time to discharge from the emergency department post stimulation
Measured: Duration of stay in emergency room - up to approximately 6 hours.
Number of Participants With Requirement for Concomitant Medications
Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation
Measured: Duration of stay in emergency room, up to approximately 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionJul 2012
Why it stopped: Slow enrollment
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elmin Steyn, MD, Principal investigatorZunaid Mohammed, MD, Principal investigator, unafiliatedRobert Johnson, Principal investigator, unafiliatedDale Cilliers, Principal investigator, unafiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385306
- Sponsor's protocol ID
- BC-SA-01
- Acronym
- BC-SA-01
- Status last verified
- Oct 2018
- First submitted
- 17 Jun 2011
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Steyn E, Mohamed Z, Husselman C. Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations-results from an initial case series. Int J Emerg Med. 2013 Mar 19;6(1):7. doi: 10.1186/1865-1380-6-7.
PubMed 23510361
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
- ClinicalTrials.gov ID
- NCT01385306
- Acronym / sponsor ID
- BC-SA-01 / BC-SA-01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Posted 10 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.
Detailed description
The purpose of the study was to collect initial safety and efficacy information of use of the AlphaCore System by clinicians in an emergency setting as an adjunctive treatment to standard of care for the relief of acute bronchoconstriction. After consent was obtained and screening completed, subjects were stimulated two times, 30 minutes apart, for 90 seconds each. Subjects were assessed prior to and immediately post the first stimulation and at 15, 30, 60, and 90 minutes; follow was also conducted at day 7 and day 30.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AlphaCore System | Experimental | Device: AlphaCore Systemnon-invasive vagus nerve stimulation (nVNS) using the AlphaCore System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is between the ages of 18 and 70 years.
- Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
- Has an FEV1<60% predicted.
- Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED.
- Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
Key exclusion criteria (18 listed)
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
- Is at risk of imminent respiratory collapse:
- Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
- Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has suspected or confirmed sepsis.
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 SystemNon-invasive neurostimulation of the vagus nerve | Device | AlphaCore System |
Primary outcome
Number of Participants With Adverse Events
Time frame: 30 days
Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.
4 secondary outcomes
Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes
Time frame: 30 minutes
Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes
Time frame: 30 minutes
Time to Discharge From the Emergency Department
Time frame: Duration of stay in emergency room - up to approximately 6 hours.
Number of Participants With Requirement for Concomitant Medications
Time frame: Duration of stay in emergency room, up to approximately 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23510361Steyn E, Mohamed Z, Husselman C. Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations-results from an initial case series. Int J Emerg Med. 2013 Mar 19;6(1):7. doi: 10.1186/1865-1380-6-7.
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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.
Elmin Steyn, MD principal investigator
Zunaid Mohammed, MD principal investigator
unafiliated
Robert Johnson principal investigator
unafiliated
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlphaCore System in people with Asthma, run by ElectroCore INC at 5 sites in South Africa.
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 18 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: stopped early, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa. 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. 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 10 Oct 2018). 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?
Number of Participants With Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385306, which also lists 1 linked publication.
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 Nov 2018.