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

Emphysema Clinical Trial

— LuReCAA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02273349
• Other study ID #: PL001-AATD
• Status: Withdrawn
• Phase: N/A
• First received: October 21, 2014
• Last updated: May 1, 2017
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2017
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Alpha-1-Antitrypsin Deficiency
• Chronic Obstructive Lung Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• Lung Volume Reduction Coil (PneumrX Inc.)
Endoscopic Lung Volume Reduction

Locations

Country	Name	City	State
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen
Germany	University Hospital of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Percent change in FEV1 from Baseline (Pre-Treatment Visit)	Lung function	6 and 12 months
Secondary	Decrease in the Residual Volume and the RV/TLC ratio	Lung function	6 and 12 months
Secondary	Improvement in the 6 minute walk distance	6MWT	6 and 12 months
Secondary	Changes in mMRC Dyspnoe Scale	mMRC	6 and 12 months