COPD, Lung Diseases, Pulmonary Emphysema
Conditions
Keywords
PLVR, BLVR, AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction, biologic lung volume reduction, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive
Brief summary
The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.
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
The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
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.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Volume of Lung | 12 weeks following treatment | Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 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) | 12 weeks following treatment | Change from baseline at 12 weeks in FEV1 |
| Change in Forced Vital Capacity (FVC) | 12 weeks following treatment | Change from baseline at 12 weeks in FVC |
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | 12 weeks following treatment | Change from baseline at 12 weeks in RV/TLC |
| Change in Medical Research Council Dyspnea (MRCD) score | 12 weeks following treatment | Change from baseline at 12 weeks in MRCD score |
| Change in St. George's Respiratory Questionnaire (SGRQ) domain score | 12 weeks following treatment | Change from baseline at 12 weeks in SGRQ total domain score |
| Change in distance walked in six minutes | 12 weeks following treatment | Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT) |
Countries
Israel
Outcome results
None listed