- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01532817
Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device
Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma
The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma.
Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92123
- Allergy and Asthma
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Minnesota
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Minneapolis, Minnesota, 미국, 55402
- CRI
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- Vital Prospects Clinical Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
INCLUSION CRITERIA: VISIT 1
- Is able to give written Informed Consent.
- Is between the ages of 18 and 65 years, male or female.
- Has a known history of mild to moderate asthma for at least 1 year as defined by GINA Guidelines.
- Is using a short acting beta-agonist for relief/rescue of asthma..
- At Visit 1, demonstrates current or historical (within 1 year) FEV1 reversibility of at least 12% (and 200ml) or greater within 15-30 minutes following administration of 4 inhalations of albuterol.
EXCLUSION CRITERIA: VISIT 1
- 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.
- Has known or suspected moderate to severe 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.
- Has experienced recent clinically significant changes in blood pressure, has uncontrolled high blood pressure, or is presently receiving pressors to maintain blood pressure.
- 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.
- Has been implanted with metal cervical spine hardware.
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizures.
- Is pregnant or nursing, or of childbearing years 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 a relative of or an employee of the Investigator or the clinical study site.
INCLUSION CRITERIA: VISIT 2
- No changes have occurred in the patient's health or status relative to the original inclusion and exclusion criteria and the patient continues to be eligible for participation in the study.
- Either (i) develops subjective symptoms of asthma (wheezing, shortness of breath, cough) for which the patient would normally self-medicate with a short acting beta agonist, and/or (ii) documents a drop of 20% from screening PEF scores as recorded in their patient diary.
- At Visit 2, FEV1 is the same or lower than the screening FEV1 previously measured at visit 1 or the PEF is the same or lower than the screening previously measured at Visit 1.
EXCLUSION CRITERIA: VISIT 2
- The patient self-administered a short-acting beta agonist within 6 hours prior to onset of asthma symptoms.
- The patient induced an asthma exacerbation by withholding their pre-treatment medication used for exercise-induced bronchoconstriction (EIB).
Has signs and symptoms of asthma instability at Visit 2:
- Lung Function: FEV1 < 50 % predicted.
- Signs and symptoms of extreme respiratory distress at rest.
- Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc.).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: alphacore
noninvasive neurostimulation of the vagus nerve
|
A single 90 second stimulation to the vagus nerve on the right side of the neck
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety- Number of Participants With Adverse Events
기간: From time subject signs the consent through the 1-week follow-up visit
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Safety- number of participants with adverse events, including device-related, serious or unanticipated
|
From time subject signs the consent through the 1-week follow-up visit
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: John Erico, ElectroCore INC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .