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LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)

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: NCT02059057
Recruitment Status : Terminated (FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up)
First Posted : February 11, 2014
Results First Posted : September 25, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Brief Summary:
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).

Condition or disease Intervention/treatment Phase
Emphysema Device: LVRC System Not Applicable

Detailed Description:
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Actual Study Start Date : December 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: LVRC System Device: LVRC System



Primary Outcome Measures :
  1. Mean Change in Six Minute Walk Test (6MWT) [ Time Frame: Change in Baseline to 12 months ]
    Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.


Secondary Outcome Measures :
  1. Mean Percent Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Change in Baseline to 12 months ]
    The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.

  2. Mean Change in Residual Volume (RV) [ Time Frame: Change in Baseline to 12 months ]
    Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.

  3. Mean Change in St. Georges Respiratory Questionnaire (SGRQ) [ Time Frame: Change in Baseline to 12 months ]

    Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD.

    It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale)

    Scores range from 0 to 100, with higher scores indicating more limitations.

    A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.




Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009.
  2. Subject has post-bronchodilator FEV1 ≤45% predicted.
  3. Subject has residual volume (RV) ≥175% predicted.
  4. Subject has stopped smoking for at least 8 weeks prior to entering the study, as confirmed by a Cotinine test or other appropriate diagnostic test.
  5. Subject has read, understood and signed the Informed Consent form.
  6. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.

Exclusion Criteria:

  1. Subject has severe homogeneous emphysema as determined by the Core Radiology Lab
  2. Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
  3. Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma.
  4. Subject has DLCO <20% of predicted.
  5. Subject has severe gas exchange abnormalities as defined by:

    PaCO2 >55 mm Hg PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)

  6. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
  7. Subject has severe pulmonary hypertension. If pulmonary hypertension is present, "severe" is defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
  8. Subject has an inability to walk >140 meters (150 yards) in 6 minutes.
  9. Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
  10. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  11. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  12. Subject has clinically significant bronchiectasis.
  13. Subject has giant bullae >1/3 lung volume.
  14. Subject has had previous LVR surgery, lung transplantation, lobectomy, LVR devices or other devices to treat COPD in either lung.
  15. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study.
  16. Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
  17. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  18. Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
  19. Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
  20. Subject has a known sensitivity to drugs required to perform bronchoscopy.
  21. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
  22. Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

    -


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): NCT02059057


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Locations
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United States, Alabama
University of Alabama Lung Health Center
Birmingham, Alabama, United States, 35294
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, United States, 94040
United States, Connecticut
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States, 61606
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York Presbyterian Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple
Philadelphia, Pennsylvania, United States, 19140
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-6300
United States, Texas
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States, 78229-3900
United States, Washington
Franciscan Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States, 53792
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Quebec, Canada
France
Centre Hospitalier Universitaire de Nice
Nice, France, CS 51069
CHU de Reims - Hopital Maison Blanche
Reims, France, 51092
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 3150-3610536
United Kingdom
Royal Brompton Hospital & Chelsea Westminster
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
PneumRx, Inc.
  Study Documents (Full-Text)

Documents provided by PneumRx, Inc.:
Study Protocol  [PDF] August 24, 2015
Statistical Analysis Plan  [PDF] July 7, 2017


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Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT02059057     History of Changes
Other Study ID Numbers: CLN0016
First Posted: February 11, 2014    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: August 21, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases