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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720680
• Other study ID #: PML_DOC_1202
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: June 27, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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)	No