Chronic Obstructive Pulmonary Disease(COPD), Lung Diseases, Pulmonary Emphysema
Conditions
Keywords
Polymeric Lung Volume Reduction (PLVR), Bolilogic 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 assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.
Detailed description
Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come. The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.
Interventions
DEVICEAeriSeal System
Not applicable. Follow-Up study only.
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 been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Percent Volume of Lung | 48 Weeks following treatment | Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in FEV1 |
| Change in Forced Vital Capacity (FVC) | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in FVC |
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in RV/TLC |
| Change in Medical Research Council Dyspnea (MRCD) score | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in MRCD score |
| Change in St. George's Respiratory Questionnaire (SGRQ)domain score | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in SGRQ total domain score |
| Change in distance walked in six minutes | 24 and 48 weeks following treatment | Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT) |
Countries
Israel
Outcome results
None listed