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Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01608490
First received: May 26, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System


Condition Intervention Phase
Emphysema
Device: RePneu Lung Volume Reduction Coil System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

Resource links provided by NLM:


Further study details as provided by PneumRx, Inc.:

Primary Outcome Measures:
  • mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups [ Time Frame: baseline through 12 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean absolute difference in SGRQ, 6MWT (responder analysis) and mean percent change in FEV1 comparing BL to 12 months, between Treatment arms. [ Time Frame: BL to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 315
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RePneu Lung Volume Reduction Coil System
The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
Device: RePneu Lung Volume Reduction Coil System
The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
No Intervention: Control arm is standard medical care
The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Detailed Description:

This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is greater than or equal to 35 yrs of age
  • CT Scan indicates bilateral emphysema
  • Subject has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Subject has Total Lung Capacity >100% predicted
  • Subject has residual volume (RV) greater than or equal to 175% predicted
  • Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4
  • 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.
  • Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing.
  • Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
  • Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form.

Exclusion Criteria:

  • Subject has severe homogeneous emphysema determined by Core Radiology Lab.
  • 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.
  • Subject has a change in FEV1 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
  • Subject has DLCO of less than 20% of predicted.
  • Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).
  • Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
  • Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg and/or echocardiogram
  • Subject has an inability to walk >140m (150 yd) in 6 minutes
  • 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.
  • Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  • Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  • Subject has clinically significant bronchiectasis.
  • Subject has giant bullae >1/3 lung volume
  • Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices in either lung.
  • Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
  • Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.
  • Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  • Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.
  • 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.
  • Subject has a sensitivity or allergy to Nickel.
  • Subject has a known sensitivity to drugs required to perform bronchoscopy.
  • Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608490

  Hide Study Locations
Locations
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, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
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
University of Illinois Hospital and Health Center
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States, 61606
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21237
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
Germany
Thoraxklinik University of Heidelberg
Heidelberg, Germany, D-69126
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
United Kingdom
Royal Brompton Hospital & Chelsea Westminster
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Charlie Strange, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01608490     History of Changes
Other Study ID Numbers: CLN0009
Study First Received: May 26, 2012
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by PneumRx, Inc.:
COPD
RePneu

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014