Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema

The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.

Inclusion Criteria:

• Homogeneous emphysema
• 15% ≤ FEV1 ≤ 45% predicted
• TLC > 100% predicted
• RV ≥ 200% predicted
• 6MWT ≥ 150 m
• Non-smoker > 8 weeks prior to study entry
• Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

• Active pulmonary infection
• More than 3 exacerbations with hospitalizations over the past 12 months
• Pulmonary hypertension (sPAP > 45 mmHg)
• MI or other relevant CV events in the past 6 months
• Alpha-1 antitrypsin deficiency
• Bronchiectasis
• Prior LVR or LVRS procedure
• > 20% difference in perfusion between right and left lung
• Hypercapnia (paCO2 > 55 mmHg
• Asthma
• Use of more than 25 mg/day prednisolone or equivalent
• Severe bullous emphysema
• Systemic or malignant disease with high death probability within 12 months