Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Brief Summary: The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.


Options:
A: Inclusion criteria:

* Dyspnea at rest or at minimal physical activity, severe limitation of exercise capacity (6-min walk distance \< 350 m).
* Acceptance of an increased perioperative mortality (approximately 2 %) and/or morbidity (long lasting hospitalization due to prolonged air leaks)
* COPD (GOLD guidelines) with severe obstructive ventilatory defect (FEV1 \<35% predicted)
* Functional aspects of lung emphysema, i.e. irreversible hyperinflation with a residual volume to total lung capacity ratio (RV/TLC) of \>0.65 and an impaired total lung diffusion capacity (DLCO), usually \< 40% predicted.
* Pulmonary emphysema confirmed by high resolution computer tomography

Exclusion criteria: - Current smokers

* Age \> 75years
* "Vanishing" lung or diffuse lung emphysema on CT, FEV1 \<20% predicted and DLCO \<20% predicted, and hypercapnia (PaCO2 \>7.3kPa)
* Overt active coronary artery disease, severe left ventricular function impairment
* Pulmonary hypertension with a mean pulmonary artery pressure \>35 mmHg at rest
* Acute bronchopulmonary infection, bronchiectasis on high resolution tomography
* Pulmonary cachexia (body mass index \<18kg/m2)
* Neoplastic disease with a life expectancy of less than 2 years
* Addiction to alcohol/drugs
* Relevant renal (creatinine \>150ug/ml), active gastroenterological (GI-bleeding in the previous year, abnormal liver function, active inflammatory bowel disease) or active neurological disease.
B: Inclusion Criteria:

* clinical diagnosis of advanced upper lobe emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist \& inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted \& experiencing \< 30% or 300 mL improvement using bronchodilator; total lung capacity \> 110% predicted; residual volume \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous emphysema
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or\> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
* history of renal infarction or renal failure
C: Inclusion Criteria:

* clinical diagnosis of advanced upper lobe predominant emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted and experiencing \< 30% or 300 mL improvement using bronchodilator; TLC \> 110% predicted; RV \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or \> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
D: Inclusion Criteria:

* Heterogeneous emphysema with upper lobe predominance in both lungs
* FEV1 between 20% and 45% predicted
* Residual volume (RV) \> 150% predicted
* Post-rehabilitation 6-minute walk test \> 140 meters

Exclusion Criteria:

* More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
* FEV1 \< 20% predicted
* DLCO \< 20% predicted or immeasurable DLCO
* Body mass index (BMI) \< 18kg/m2 or \> 32 kg/m2
* History of any of the following:

  * Left ventricular ejection fraction (EF) ≤ 40%
  * Stroke
  * Myocardial infarction or acute coronary syndrome in previous year
  * Hospitalization due to left ventricular failure in previous 3 years

Answer: B