Clinical trial NCT01720680: Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD
Official title: Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Functional Imaging
Patient Reported Outcome (PRO)
Lung Function
AlphaCore
Computational Fluid Dynamics
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Changes in functional imaging parameters
timeFrame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
Secondary outcomes:
measure: Changes in lung function parameters
timeFrame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
measure: Changes in patient reports outcomes (PROs)
timeFrame: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: