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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

October 25, 2012
June 27, 2013
October 2012
October 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01720680 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
COPD
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01720680
PML_DOC_1202
No
Wilfried De Backer, University Hospital, Antwerp
University Hospital, Antwerp
Not Provided
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
University Hospital, Antwerp
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP