Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.


Options:
A: Inclusion Criteria:

1. Willing and able to provide informed consent
2. Age ≥ 40 years
3. On optimal medical therapy\* for more than 1 month
4. Advanced upper lobe predominant emphysema confirmed by CT scan
5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)
6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)
7. 6MWT distance ≥ 150 m post pulmonary rehab
8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH:

   1. FEV1 \< 50% predicted
   2. FEV1/FVC ratio \< 70%
9. Plethysmographic lung volumes showing BOTH:

   1. TLC \> 100% predicted
   2. RV \> 150% predicted
10. DLco ≥ 20% and ≤ 60% predicted
11. Blood gases and oxygen saturation showing BOTH:

    1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2
    2. PaCO2 \< 65 torr
12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks

Exclusion Criteria:

1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)
3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks
4. Use of systemic steroids \> 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications

   Exclusion Criteria (continued):
5. a-1 antitrypsin serum level of \< 80 mg/dL (immunodiffusion) or \< 11 µmol/L (nephelometry)
6. CT scan: Presence of any of the following radiologic abnormalities:

   1. Pulmonary nodule on CT scan greater than 1.0 cm in diameter
   2. Radiologic picture consistent with active pulmonary infection
   3. Significant interstitial lung disease
   4. Significant pleural disease
   5. Giant bullous disease
7. Clinically significant asthma
8. Clinically significant bronchiectasis
9. Pulmonary hypertension
10. Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation
11. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing
12. Body mass index \< 15 kg/m2 or \> 35 kg/m2
13. Female patient pregnant or breast-feeding or planning to be pregnant in the next year
14. Any abnormal screening laboratory test result
15. Significant comorbidity including any of the following:

    1. HIV/AIDs
    2. Active malignancy
    3. Stroke or TIA within 12 months
    4. Myocardial infarction within 12 months
    5. Congestive heart failure within 12 months
16. Any condition that would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
B: Inclusion Criteria:

* Between 40 and 74 years of age
* Predominantly upper lobe emphysema and severe dyspnea
* Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
* Physical ability to participate in the study by performing a 6-minute walk distance of \> 140m
* No cigarette smoking for 4 months and willing to abstain throughout the study
* Severe airflow obstruction defined by FEV1 45% of predicted
* Severe hyperinflation defined by: TLC \> 100% of predicted and RV \> 150% of predicted

Exclusion Criteria:

* Between 70 and 74 years of age and an FEV1 or DLCO \< 20% of predicted
* Severe gas exchange abnormalities
* Major medical disease that will limit evaluation, participation or follow-up
* Active asthma component to their disease
* Giant bulla (\> 1/3 volume of lung)
* Severe pulmonary hypertension
* Requirement for \> 6L02 to keep saturation \> 90% with exercise
* Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
C: Inclusion Criteria:

* Patient greater than or equal to 35 years of age
* High resolution CT scan indicates unilateral or bilateral emphysema
* High resolution CT scan indicates homogeneous or heterogeneous emphysema
* Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
* Total Lung Capacity greater than 100% predicted
* Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
* Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
* Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

* Patient has a change in FEV1 greater than 20% post-bronchodilator
* Patients DLCO less than 20% predicted
* Patient has a history of recurrent clinically significant respiratory infection
* Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
* Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
* Patient has clinically significant bronchiectasis
* Patient has giant bullae greater than 1/3 lung volume
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies with 30 days prior to this study
* Patient is taking greater than 20 mg prednisone (or similar steroid) daily
* Patient is on Plavix or has not been weaned off prior to procedure
* Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
D: Men and women with end-stage emphysema.

Answer: A