Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients

Conditions
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Alpha-1-Antitrypsin Deficiency, Chronic Obstructive Lung Disease, Emphysema

Intervention / Treatment
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* Device: Lung Volume Reduction Coil (PneumrX Inc.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 18 years of age, diagnosed with AATD emphysema 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). Patient has post- bronchodilator FEV1 less than or equal to 45% predicted Total Lung Capacity > 100% Residual Volume (RV) >175% predicted Patient has stopped smoking for a minimum of 8 weeks prior to entering the study Patient has read, understood and signed the Informed Consent form Patient is willing and able to attend all required follow-up visits Patient is willing and able to undergo bilateral LVRC treatment Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy Exclusion Criteria: Patient has a change in FEV1 > 20% post-bronchodilator. Patients DLCO < 20% predicted Patient has a history of recurrent clinically significant respiratory infection Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and or evidenced by echocardiogram Patient has an inability to walk >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 moderate sedation or anesthesia Patient has clinically significant bronchiectasis Patient has giant bullae > 1/3 lung volume Patient has had previous LVR surgery, lung transplant or lobectomy Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study Patient is taking > 20mg prednisone (or similar steroid) daily 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 Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes Patient has severe homogeneous emphysema by CT scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.) | Device: Lung Volume Reduction Coil (PneumrX Inc.)<br>* Endoscopic Lung Volume Reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit | Quality of Life | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in FEV1 from Baseline (Pre-Treatment Visit) | Lung function | 6 and 12 months | 
| Decrease in the Residual Volume and the RV/TLC ratio | Lung function | 6 and 12 months | 
| Improvement in the 6 minute walk distance | 6MWT | 6 and 12 months | 
| Changes in mMRC Dyspnoe Scale | mMRC | 6 and 12 months |