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

NCT02273349 | Withdrawn

• 1 other identifier: PL001-AATD
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Alpha-1-Antitrypsin Deficiency; Chronic Obstructive Lung Disease; Emphysema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent change in FEV1 from Baseline (Pre-Treatment Visit)

  6 and 12 months

• Decrease in the Residual Volume and the RV/TLC ratio

  6 and 12 months

• Improvement in the 6 minute walk distance

  6 and 12 months

• Changes in mMRC Dyspnoe Scale

  6 and 12 months

Other Outcomes (1)

• Number and type of device-related and procedure-related serious adverse events (SAE) attributed to the use of RePneu LVRC

  up to 6 months

Study Arms (1)

Treatment

EXPERIMENTAL

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.)

Interventions

Lung Volume Reduction Coil (PneumrX Inc.) DEVICE

Endoscopic Lung Volume Reduction

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (2)

Rigshospitalet, University of Copenhagen

Copenhagen, DK-2100, Denmark

Location

University Hospital of Saarland

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

DK (1); DE (1)