AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation (CV+)

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