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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Emphysema; Chronic Obstructive Lung Disease; Alpha-1-Antitrypsin Deficiency
• Intervention / Treatment: Device: Lung Volume Reduction Coil (PneumrX Inc.)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet, University of Copenhagen
• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • University Hospital of Saarland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.); Endoscopic Lung Volume Reduction

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of device-related and procedure-related serious adverse events (SAE) attributed to the use of RePneu LVRC	SAE device and procedure related	up to 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Saarland

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Liver Diseases; Genetic Diseases, Inborn; Subcutaneous Emphysema; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema; Alpha 1-Antitrypsin Deficiency
• Other Study ID Numbers: PL001-AATD