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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01720680
First received: October 25, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose
  • 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).

Condition Intervention
COPD
Radiation: Low dose multislice CT thorax
Device: AlphaCore® device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Changes in functional imaging parameters [ Time Frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in lung function parameters [ Time Frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device ] [ Designated as safety issue: No ]
    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) [ Time Frame: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720680

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, Prof. Dr., University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01720680     History of Changes
Other Study ID Numbers: PML_DOC_1202
Study First Received: October 25, 2012
Last Updated: June 27, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
COPD
Functional Imaging
Patient Reported Outcome (PRO)
Lung Function
AlphaCore
Computational Fluid Dynamics

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014