AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation
AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation
The purpose of this study is to characterize the safety and efficacy of the AeriSeal System
 in patients with advanced upper lobe predominant emphysema and significant collateral
 ventilation as determined by the Chartis System.
This is an investigator initiated, open-label, uncontrolled study to prospectively
 characterize the safety and efficacy of the AeriSeal System in patients with advanced upper
 lobe predominant emphysema found to have significant collateral ventilation using the Chartis
 System.
Inclusion Criteria:

 -  Willing and able to provide informed consent and to participate in the study

 -  Diagnosis of advanced emphysema (GOLD Stage III or Stage IV disease)

 -  Radiologic evidence of non-bullous upper lobe predominant heterogeneous emphysema with
 at least 2 target sites deemed appropriate for treatment evident by CT imaging

 -  DLco between 20 and 60% predicted

 -  Positive Collateral Ventilation as determined by the Chartis® System

 -  Clinically significant dyspnea (defined as a MRC dyspnea score of 2 or greater at
 Screening)

 -  Failure of standard medical therapy to provide adequate relief of symptoms (defined as
 regular use of standard medication for more than 1 month prior to Screening; standard
 medications include at least an inhaled beta agonist and inhaled anticholinergic
 unless medically contraindicated or prior medical failure)

 -  Significant airflow obstruction as demonstrated by Spirometry 15 minutes after
 administration of bronchodilator with:

 -  5% < FEV1 < 50% predicted using the ATS recommended calculation for expected value

 -  FEV1/FVC ratio <70%

 -  Physiological evidence of hyperinflation with Lung volumes (plethysmographic) of:

 -  TLC > 100% predicted using the ATS recommended calculation for expected value

 -  RV > 135% predicted using the ATS recommended calculation for expected value

 -  Six-Minute Walk Test distance ≥ 150 m

 -  Abstinence from inhaled tobacco use for at least 16 weeks prior to the initial
 Screening visit until the end of the study

 -  Female patients are either post-menopausal or surgically sterile. Women with
 child-bearing potential will not be included in this study

 Exclusion Criteria:

 -  Alpha-1 antitrypsin serum level of < 80 mg/dL (i.e. < 11 micro mol/L) at Screening

 -  Body mass index < 15 kg/m2 or > 35 kg/m

 -  Clinically significant asthma, chronic bronchitis or bronchiectasis as determined by
 the Investigator, or a significant COPD exacerbation within the past 4 months

 -  Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins,
 oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including
 aspirin and clopidogrel are permitted) or investigational medications within 4 weeks
 of Screening

 -  Allergy or sensitivity to medications required to safely perform AeriSeal System
 treatment under general anesthesia or conscious sedation

 -  Participation in an investigational study of a drug, biologic, or device not currently
 approved for marketing within 30 days prior to the Screening visit

 -  Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung
 transplantation, prior airway stent placement, prior pleurodesis, or prior
 endobronchial lung volume reduction therapy of any type

 -  Significant co-morbidity that carries prohibitive risks (e.g., HIV/AIDS, cancer) or is
 associated with less than 2-year expected survival

 -  Blood gases and oxygen saturation:

 -  SpO2 ≤ 90% on > 4 L/min supplemental O2, at rest

 -  PaCO2 ≥ 55mmHg

 -  DLCO < 20% or > 60% predicted for patients with heterogeneous emphysema

 -  Chest CT scan: Presence of any of the following radiologic abnormalities:

 -  Pulmonary nodule on CT scan greater than 1.0 cm in diameter (Does not apply if
 present for 2 years or more without increase in size or if proven benign by
 biopsy/PET)

 -  Giant Bullous Disease

 -  Radiologic picture consistent with active pulmonary infection, e.g., unexplained
 parenchymal infiltrate

 -  Significant interstitial lung disease (based upon investigator judgment)

 -  Significant pleural disease (based upon investigator judgment)

 -  Any condition that the Investigator believes would interfere with the intent of
 the study or would make participation not in the best interest of the patient