Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD

Study Overview
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Brief Summary
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Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore® device on central and peripheral airway dimensions in patients with COPD. Indication: COPD patients Study Design: Open-label, prospective design Study Phase: II Test treatment duration: 1 day Test treatment: AlphaCore® device Dosage regimen: 1 session of stimulation during 90 seconds Patient number: up to 10 evaluable patients with COPD Patient age: ≥ 18 years Sex: male or female Primary objective: The evaluation of the effect of the AlphaCore® device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD). Secondary objectives: The assessment of the effect of the AlphaCore® device on lung function (spirometry, diffusion and resistance) and on patient reported outcomes (PRO's).

Official Title
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Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD

Conditions
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COPD

Intervention / Treatment
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* Radiation: Low dose multislice CT thorax
* Device: AlphaCore® device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a documented diagnosis of COPD Male or female patients aged ≥18 years Patients with a co-operative attitude to be treated with the AlphaCore® device Patients should take anti-cholinergics Female patient of childbearing potential who confirm to use a contraception method during the study Written informed consent obtained Exclusion Criteria: Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period Inability to carry out pulmonary function testing Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study Patients with an electrical and/or neurostimulator device (e.g. a cardiac pacemaker, a vagal neurostimulator, a defibrillator, a cochlear implant, …) Patients with an abscess or other infection or lesion (incl. lymphadenopathy) at the therapy head placement site Patients with a compromised cervical anatomy (such as from scaring, infection or suspected carotid artery disease) or a cervical vagotomy Patients with a history of carotid endarterectomy or vascular neck surgery on the right side Patients with coagulopathy, irregular heart rhythm or that are on pressor medication Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study Patients who received any investigational new drug within the last 4 weeks prior to the screening visit Patients treated with any non-permitted concomitant medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Low dose multislice CT thorax|All patients will have 2 low dose multi-slice CT's at visit 2: one CT pre-dose and one CT 1 to 3 hours post-dose.|
|Device: AlphaCore® device|All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional imaging parameters | The primary objective of this study is to evaluate the effect of the AlphaCore® on central and peripheral airway dimensions with functional imaging using airway segmentation and computational methods (CFD). | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lung function parameters | The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L. | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device | 
| Changes in patient reports outcomes (PROs) | The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L. | At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Functional Imaging, Patient Reported Outcome (PRO), Lung Function, AlphaCore, Computational Fluid Dynamics