The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.

The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves

The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Endobronchial Valve (EBV); Device: Lung Sealant

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• i. 18-85 years of age
• ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
• iii. Residual Volume (RV) > 175%
• iv. 6 min walk test > 150 m
• v. Completed a course of Pulmonary rehabilitation
• vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
• vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU

Exclusion Criteria:

• i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
• ii. Acute respiratory tract infections
• iii. Significant bronchiectasis,
• iv. Co-existing interstitial lung diseases, pneumothorax,
• v. Known active malignancy
• vi. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collateral Ventilation Negative; Collateral Ventilation Negative participants will have endobronchial valve implant	Device: Endobronchial Valve (EBV); The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.; Other Names: Zephyr Endobronchial Valve System
Experimental: Collateral Ventilation Positive; Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant	Device: Endobronchial Valve (EBV); The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.; Other Names: Zephyr Endobronchial Valve System; Device: Lung Sealant; The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.; Other Names: AeriSeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)	Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state	4 weeks post lung sealant application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with improved lung functioning as measured by lung function tests	Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test	12weeks and 52 weeks post valve implant
Changes Lung volume	Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR)	12weeks and 52 weeks post valve implant

Collaborators and Investigators

• Sponsor: Macquarie University, Australia
• Investigators: Principal Investigator: Alvin J Ing, MBBS, MD, FRACP, Clinical Professor and Respiratory Physician

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AI-MCVP-COPD-ELVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes