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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: Lung Sealant; Device: Endobronchial Valve (EBV)

• Registration Number: NCT05396131
• Lead Sponsor: Macquarie University, Australia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-20
• Study First Submitted: 2021-09-20
• Primary Completion: 2022-01-07
• Study Completion: 2022-01-07
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collateral Ventilation Positive	Lung Sealant	Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant
Collateral Ventilation Negative	Endobronchial Valve (EBV)	Collateral Ventilation Negative participants will have endobronchial valve implant
Collateral Ventilation Positive	Endobronchial Valve (EBV)	Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant

Primary Outcome Measures

Name	Time	Method
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)	4 weeks post lung sealant application	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

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

Trial Locations

Locations (1)

Macquarie University; 🇦🇺 Macquarie Park, New South Wales, Australia