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Completed

NCT Number: NCT01720680

Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in functional imaging parameters

    Time frame: 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 outcomes

  1. Changes in lung function parameters

    Time frame: 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.

  2. 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)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2012
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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