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

Macquarie University

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05396131

AI-MCVP-COPD-ELVR

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Collateral Ventilation Negative

Active Comparator group

Description:

Collateral Ventilation Negative participants will have endobronchial valve implant

Treatment:

Device: Endobronchial Valve (EBV)

Collateral Ventilation Positive

Experimental group

Description:

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

Treatment:

Device: Endobronchial Valve (EBV)

Device: Lung Sealant