None listed
Conditions
Brief summary
Endoscopic Lung volume Reduction (ELVR) is an established treatment for severe Chronic Obstructive Pulmonary Disease (COPD). Endobronchial valves are an accepted management option for achieving lung volume reduction, but are not suitable for every patient. Over 50% of patients are unable to have one way valves because of anatomical deficits ('fissures') in the lobes of the lung. Patients with >95% fissure completeness are eligible for valves; patients with 80-95% fissure completeness are further assessed for possible valve options but currently in Australia, there are no therapeutic options for patients with fissure completeness < 80%. This study seeks to expand the ELVR technique to patients not suitable for ELVR with standard approaches (such as endobronchial valves) by using segmental delivery of a polymer foam sealant called AeriSeal ® in patients with a fissure completeness < 80% for the targeted lobe. Polymer sealant allows lung volume reduction in these COPD patients who have no other alternatives.
Interventions
Currently in Australia, there are no therapeutic options for Endoscopic Lung Volume Reduction (ELVR) in patients with a fissure < 80% complete for the targeted lobe; considering the improvements observed in patients treated with AeriSeal as an independent therapy, and when used in conjunction with endobronchial valves, we propose that therapy with AeriSeal as a stand-alone therapy be investigated in severe and very severe COPD where the targeted lobe for ELVR has a fissure integrity less than 80
Currently in Australia, there are no therapeutic options for Endoscopic Lung Volume Reduction (ELVR) in patients with a fissure < 80% complete for the targeted lobe; considering the improvements observed in patients treated with AeriSeal as an independent therapy, and when used in conjunction with endobronchial valves, we propose that therapy with AeriSeal as a stand-alone therapy be investigated in severe and very severe COPD where the targeted lobe for ELVR has a fissure integrity less than 80%. Specifically, the segmental application of AeriSeal will be to the 3 most destroyed segments per lung based on emphysema scoring, regardless of lobe, in severe and very severe COPD patients with less than 80% complete fissures who otherwise meet the criteria for ELVR. Patients with fissure completeness greater than 95% are eligible to participate in the control group. Patients with fissure completeness less than 80% are eligible to participate in the test (AeriSeal) group. The AeriSeal® System is manufactured by Pulmonx Corporation, Redwood City, CA USA and consists of the following components: • AeriSeal Foam Components • AeriSeal Balloon Catheter Preparation Kit. o Mixing accessories o AeriSeal Balloon Catheter AeriSeal is a polymer sealant and it is administered under a general anaesthetic by bronchoscopy, which is a small tube with a camera at the end, that goes into the lungs from the mouth. Once administered, it stays in the body permanently. The procedure takes up to approx one hour each time and the treatment is given twice with the second procedure approx 4-6 weeks after the first. The administration is done by a respiratory medicine specialist and the patients in this group receive the AeriSeal alone; that is, these patients do not receive valves.
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is willing and able to provide Informed Consent and to participate in the study. 2. Subject is greater than or equal to 18 years of age at the time Informed Consent signature. 3. FEV1 20 - 50% predicted 4. RV greater than 175% predicted 5. 6 minute walk test greater than 150 m 6. Subject has stopped smoking for at least 8 weeks prior to consent 7. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy 8. Appropriate segments to target able to be determined by Interventional Pulmonology Multidisciplinary Meeting. 9. Completed a course of Pulmonary Rehabilitation within 12 months prior to baseline visit 10. V/Q with 3D CT SPECT scan shows patients less than 80% or greater than 95% fissure completeness
Exclusion criteria
1. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment 2. Acute respiratory tract infections 3. Significant bronchiectasis 4. Co-existing interstitial lung diseases, pneumothorax, 5. Known active malignancy 6. Positive serum pregnancy test for women of child-bearing potential, or breast-feeding
Outcome results
None listed