Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Lung Diseases, Pulmonary Emphysema
Conditions
Keywords
Polymeric Lung Volume Reduction (PLVR), Biologic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.
Interventions
DEVICEAeriSeal System
AeriSeal System for Lung Volume Reduction
Sponsors
Aeris Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted. * Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS. * Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio | 12 Weeks following final treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in RV/TLC ratio | 24 and 48 weeks following treatment |
| Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator) | 12, 24, 48 weeks following treatment |
| Change from baseline in MRC dyspnea score | 12, 24, 48 weeks following treatment |
| Change from baseline in 6 minute walk test (MWT) | 12, 24, 48 weeks following treatment |
| Change from baseline in disease-specific health related quality of life assessment (SGRQ) | 12, 24, 48 weeks following treatment |
Countries
Austria, France, Germany, Israel
Outcome results
None listed