A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
- Conditions
- Other chronic obstructive pulmonary diseaseCOPD Patients With Homogeneous EmphysemaJ44
- Registration Number
- DRKS00006980
- Lead Sponsor
- Pulmonx International Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 93
1. Diagnosis of homogeneous emphysema with a heterogeneity index of < 15%
between target and adjacent lobes
2. Subjects of both genders of at least 40 years of age 3. Understand and voluntarily sign a patient informed consent form 4. Diagnosis of COPD with a 15 % predicted = FEV1= 45% predicted despite
optimal medical management 5. TLC > 100% predicted, RV = 200% predicted 6. 6MWT > 150 meters 7. Non-smoker >8weeks prior to signing the Informed Consent 8. CV negative target lobe
1. Evidence of active pulmonary infection 2. History of more than 3 exacerbations with hospitalizations over the past 12 months 3. Evidence of pulmonary hypertension (sPAP > 45mmHg) 4. Myocardial infarction or other relevant cardiovascular events in the past 6 months 5. Evidence of Alpha 1 antitrypsin deficiency
6. Evidence of severe bronchiectasis with greater than two tablespoons of sputum production per day7. Prior LVR or LVRS procedure8. Pulmonary nodule requiring follow-up within the target lobe9. > 20% difference in perfusion between left and right lung10. Pregnant or nursing women11. Hypercapnia (paCO2 > 55mmHg)12. Asthma 13. > 25mg Prednisolone (or equivalent) use/days14. Systemic or malignant disease with high probability of mortality within 12 months15. Severe bullous emphysema (> 1/3 of the Hemithorax)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr® EBV in subjects with homogeneous emphysema
- Secondary Outcome Measures
Name Time Method Evaluation of quality of life (FEV1, SGRQ, CAT, EQ-5D), exercise capacity (6-MWT), dyspnea incl. BODE, volume reduction and adverse events at 3, 6 and 12 months following placement of Zephyr® EBV in subjects with homogeneous emphysema.