Alpha-1-Antitrypsin Deficiency, Chronic Obstructive Lung Disease, Emphysema
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.
Interventions
DEVICELung Volume Reduction Coil (PneumrX Inc.)
Endoscopic Lung Volume Reduction
Sponsors
University Hospital, Saarland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patient \> 18 years of age, diagnosed with AATD emphysema 2. CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1). 3. Patient has post- bronchodilator FEV1 less than or equal to 45% predicted 4. Total Lung Capacity \> 100% 5. Residual Volume (RV) \>175% predicted 6. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study 7. Patient has read, understood and signed the Informed Consent form 8. Patient is willing and able to attend all required follow-up visits 9. Patient is willing and able to undergo bilateral LVRC treatment 10. Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy
Exclusion criteria
1. Patient has a change in FEV1 \> 20% post-bronchodilator. 2. Patients DLCO \< 20% predicted 3. Patient has a history of recurrent clinically significant respiratory infection 4. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure \>50mmHg and or evidenced by echocardiogram 5. Patient has an inability to walk \>140 meters (150 yards) in 6 minutes 6. Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc. 7. Patient is pregnant or lactating 8. Patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia 9. Patient has clinically significant bronchiectasis 10. Patient has giant bullae \> 1/3 lung volume 11. Patient has had previous LVR surgery, lung transplant or lobectomy 12. Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study 13. Patient is taking \> 20mg prednisone (or similar steroid) daily 14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or coumadin) or has not been weaned off prior to procedure 15. Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes 16. Patient has severe homogeneous emphysema by CT scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit | 6 months | Quality of Life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the 6 minute walk distance | 6 and 12 months | 6MWT |
| Percent change in FEV1 from Baseline (Pre-Treatment Visit) | 6 and 12 months | Lung function |
| Decrease in the Residual Volume and the RV/TLC ratio | 6 and 12 months | Lung function |
| Changes in mMRC Dyspnoe Scale | 6 and 12 months | mMRC |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and type of device-related and procedure-related serious adverse events (SAE) attributed to the use of RePneu LVRC | up to 6 months | SAE device and procedure related |
Countries
Denmark, Germany
Outcome results
None listed