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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Lung Sealant

Endobronchial Valve (EBV)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Macquarie University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Collateral Ventilation Negative

Collateral Ventilation Positive

Arm Description

Collateral Ventilation Negative participants will have endobronchial valve implant

Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Changes Lung volume

Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR)

Full Information

NCT ID

NCT05396131

First Posted

September 20, 2021

Last Updated

May 24, 2022

Sponsor

Macquarie University, Australia

1. Study Identification

Unique Protocol Identification Number

NCT05396131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

June 20, 2019 (Actual)

Primary Completion Date

January 7, 2022 (Actual)

Study Completion Date

January 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Macquarie University, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive. CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collateral Ventilation Negative

Arm Type

Active Comparator

Arm Description

Collateral Ventilation Negative participants will have endobronchial valve implant

Arm Title

Collateral Ventilation Positive

Arm Type

Experimental

Arm Description

Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant

Intervention Type

Device

Intervention Name(s)

Lung Sealant

Other Intervention Name(s)

AeriSeal

Intervention Description

The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.

Intervention Type

Device

Intervention Name(s)

Endobronchial Valve (EBV)

Other Intervention Name(s)

Zephyr Endobronchial Valve System

Intervention Description

The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Primary Outcome Measure Information:

Title

Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)

Description

Time Frame

4 weeks post lung sealant application

Secondary Outcome Measure Information:

Title

Number of participants with improved lung functioning as measured by lung function tests

Description

Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test

Time Frame

12weeks and 52 weeks post valve implant

Title

Changes Lung volume

Description

Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR)

Time Frame

12weeks and 52 weeks post valve implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alvin J Ing, MBBS, MD, FRACP

Organizational Affiliation

Clinical Professor and Respiratory Physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

Macquarie University

City

Macquarie Park

State/Province

New South Wales

ZIP/Postal Code

2109

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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