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

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

• 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).

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Radiation: Low dose multislice CT thorax; Device: AlphaCore® device

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (ESTIMATE): November 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Lung Function; Functional Imaging; Computational Fluid Dynamics; Patient Reported Outcome (PRO); AlphaCore
• Other Study ID Numbers: PML_DOC_1202