Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
DEVICELung Sealant
The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.
DEVICEEndobronchial Valve (EBV)
The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.
Sponsors
Macquarie University, Australia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
Australia
Outcome results
None listed