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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396131
• Other study ID #: AI-MCVP-COPD-ELVR
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2019
• Est. completion date: January 7, 2022

Study information

• Verified date: May 2022
• Source: Macquarie University, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• Endobronchial Valve (EBV)
The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Locations

Country	Name	City	State
Australia	Macquarie University	Macquarie Park	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Macquarie University, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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