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

NCT05396131 | Completed Phase 2 FDA Device

• 1 other identifier: AI-MCVP-COPD-ELVR
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  12weeks and 52 weeks post valve implant

• Changes Lung volume

  12weeks and 52 weeks post valve implant

Study Arms (2)

Collateral Ventilation Negative

ACTIVE COMPARATOR

Collateral Ventilation Negative participants will have endobronchial valve implant

Device: Endobronchial Valve (EBV)

Collateral Ventilation Positive

EXPERIMENTAL

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

Device: Lung Sealant; Device: Endobronchial Valve (EBV)

Interventions

Lung Sealant DEVICE

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

Also known as: AeriSeal

Collateral Ventilation Positive

Endobronchial Valve (EBV) DEVICE

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

Also known as: Zephyr Endobronchial Valve System

Collateral Ventilation Negative; Collateral Ventilation Positive

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Macquarie University, Australia: lead

Study Sites (1)

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

Related Publications (1)

• Ing AJ, Jayapadman A, Kim WV, Ly C, Ho-Shon K, Lilburn P, Carew A, Ng BJH, Saghaie T, Williamson JP. Reversal of collateral ventilation using endoscopic polymer foam in COPD patients undergoing endoscopic lung volume reduction with endobronchial valves: A controlled parallel group trial. Respirology. 2022 Dec;27(12):1064-1072. doi: 10.1111/resp.14338. Epub 2022 Aug 2.

  PMID: 35918295 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Alvin J Ing, MBBS, MD, FRACP

  Clinical Professor and Respiratory Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: May 31, 2022
• Study Start: June 20, 2019
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)