COPD
Conditions
Keywords
COPD, Functional Imaging, Patient Reported Outcome (PRO), Lung Function, AlphaCore, Computational Fluid Dynamics
Brief summary
* 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).
Interventions
RADIATIONLow 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.
DEVICEAlphaCore® device
All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in functional imaging parameters | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lung function parameters | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device | 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. |
| Changes in patient reports outcomes (PROs) | At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2) | 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. |
Countries
Belgium
Outcome results
None listed