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

NCT01720680 | Completed

• 1 other identifier: PML_DOC_1202
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Keywords

COPD; Functional Imaging; Patient Reported Outcome (PRO); Lung Function; AlphaCore; Computational Fluid Dynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in lung function parameters

  At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device

• Changes in patient reports outcomes (PROs)

  At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)

Interventions

Low dose multislice CT thorax RADIATION

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".

AlphaCore® device DEVICE

All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

BE (1)