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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273349
Recruitment Status : Withdrawn
First Posted : October 23, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland

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.

Condition or disease Intervention/treatment Phase
Alpha-1-Antitrypsin Deficiency Chronic Obstructive Lung Disease Emphysema Device: Lung Volume Reduction Coil (PneumrX Inc.) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients
Study Start Date : October 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : October 2015


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




Primary Outcome Measures :
  1. symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit [ Time Frame: 6 months ]
    Quality of Life


Secondary Outcome Measures :
  1. Percent change in FEV1 from Baseline (Pre-Treatment Visit) [ Time Frame: 6 and 12 months ]
    Lung function

  2. Decrease in the Residual Volume and the RV/TLC ratio [ Time Frame: 6 and 12 months ]
    Lung function

  3. Improvement in the 6 minute walk distance [ Time Frame: 6 and 12 months ]
    6MWT

  4. Changes in mMRC Dyspnoe Scale [ Time Frame: 6 and 12 months ]
    mMRC


Other Outcome Measures:
  1. Number and type of device-related and procedure-related serious adverse events (SAE) attributed to the use of RePneu LVRC [ Time Frame: up to 6 months ]
    SAE device and procedure related



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273349


Locations
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Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, DK-2100
Germany
University Hospital of Saarland
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland

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Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT02273349    
Other Study ID Numbers: PL001-AATD
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Lung Diseases
Pulmonary Emphysema
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Respiratory Tract Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action