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Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema (ELEVATE)

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ClinicalTrials.gov Identifier: NCT03360396
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Brief Summary:
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Condition or disease Intervention/treatment Phase
Emphysema Device: Endobronchial Coils Not Applicable

Detailed Description:
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Endobronchial Coils
Treatment with PneumRx Endobronchial Coil System
Device: Endobronchial Coils
Endobronchial Coil implants

No Intervention: Control
Medically-managed control group



Primary Outcome Measures :
  1. FEV1 [ Time Frame: 6 months ]
    Percent change in FEV1

  2. SGRQ [ Time Frame: 6 months ]
    Change in SGRQ score


Secondary Outcome Measures :
  1. Responder Rate [ Time Frame: 6 months ]
    percent change in subjects who achieve two or more MCIDs (6MWT >=26 meters, SGRQ <= -4 points, RV >=350 ml, FEV1 >=10%

  2. Mean Expiratory Lobar Volume [ Time Frame: 6 months ]
    change in mean expiratory lobar volume of treated lobes

  3. VC [ Time Frame: 6 months ]
    Change in vital capacity


Other Outcome Measures:
  1. Pulmonary Function - RV [ Time Frame: 6 months ]
    RV

  2. Pulmonary Function - RV/TLC [ Time Frame: 6 months ]
    RV/TLC

  3. Pulmonary Function - FEV` [ Time Frame: 6 months ]
    FEV1

  4. Pulmonary Function FEV1/FVC [ Time Frame: 6 months ]
    FEV1/FVC

  5. 6MWT [ Time Frame: 6 months ]
    change in exercise capacity (6MWT)

  6. CAT [ Time Frame: 6 months ]
    change in CAT

  7. EQ-5D [ Time Frame: 6 months ]
    change in EQ-5D

  8. Individual MCID responder rates 6MWT [ Time Frame: 6 months ]
    6MWT

  9. Individual MCID responder rates FEV1 [ Time Frame: 6 months ]
    FEV1

  10. Individual MCID responder rates SGRQ [ Time Frame: 6 months ]
    SGRQ

  11. responder rate of FEV1 [ Time Frame: 6 months ]
    responder rate defined as percent of subjects who achieve FEV1 change >= 12%

  12. SGRQ responder rate [ Time Frame: 6 months ]
    responder rate defined as percent of subjects that achieve SGRQ <= -8 points



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Read, understood and signed the Informed Consent form
  • Meets indications for use per the IFU
  • Bilateral heterogeneous and/or homogeneous emphysema
  • Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
  • Post bronchodilator Residual Volume (RV) ≥ 200% predicted
  • Post bronchodilator Total Lung Capacity (TLC) >100% pred.
  • Post bronchodilator RV/TLC > 55%
  • Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
  • Receiving optimal drug therapy and medical management according to clinical practice.
  • Performing regular physical activity, at least 2 times per week
  • Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
  • 100m ≤ 6 minute walk distance (6MWD) ≤ 450m
  • Deemed eligible per Eligibility Review Committee (ERC)

Exclusion Criteria:

  • Meets any of the contraindications listed in the IFU
  • Primary diagnosis of asthma
  • Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
  • Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
  • Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
  • Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease (predominant bulla > 8cm or 1/3 hemithorax), or severe bullous or predominant paraseptal emphysema pattern
  • Lung pathology of nodule not proven stable or benign
  • Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
  • Use of more than 10 mg/day prednisolone or equivalent dosage of a different corticosteroid
  • Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
  • Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
  • Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
  • Diagnosed with alpha-1 antitrypsin deficiency
  • DLCO < 20 %
  • Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
  • Body Mass Index (BMI) > 30

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): NCT03360396


Locations
Austria
Otto-Wagner Spital Recruiting
Wien, Austria
Contact: Marina Duller, BSc    +43664-4385355    blvr.koordinator@gmail.com   
Principal Investigator: Arschang Valipour, MD         
France
CHU Grenoble Recruiting
Grenoble, France
Contact: Raïssa Dahalani    +33476766458    RDahalani@chu-grenoble.fr   
Contact: Marie Jondot    +33476766458    MJondot@chu-grenoble.fr   
Principal Investigator: Christophe Pison, MD         
Hopital Nord APHM Not yet recruiting
Marseille, France
Contact: Hervé Dutau    04 91 96 59 71    Herve.dutau@ap-hm.fr   
Principal Investigator: Hervé Dutau         
CHU Montpellier Recruiting
Montpellier, France
Contact: Alexandre Coudrat    +33467335937    a-coudrat@chu-montpellier.fr   
Principal Investigator: Arnaud Bourdin, MD         
Hôpital Pasteur CHU de Nice Recruiting
Nice, France, 06002
Contact: Sarah Idris Khodja    +330369550645    Sarah.IDRISKHODJA@chru-strasbourg.fr   
Contact: Julien Stauder    +330369550645    julien.stauder@chru-strasbourg.fr   
Principal Investigator: Romain Kessler, MD         
Centre Hospitalier Universitaire de Nice Recruiting
Nice, France, CS 51069
Contact: Ariane Guillemart    +33492038075    guillemart.a@chu-nice.fr   
Principal Investigator: Professor Charles-Hugo Marquette, MD, PhD         
Hôpital Bichat Recruiting
Paris, France
Contact: Herve Mal, MD    +33140256912    herve.mal@bch.aphp.fr   
Principal Investigator: Herve Mal, MD         
CHU de Reims - Hopital Maison Blanche Recruiting
Reims, France, 51092
Contact: Delphine Gras    +33 (0) 3 26 78 78 28    dgras@chu-reims.fr   
Contact: Margaux Verdier    +33 (0) 3 26 78 77 67    mverdier@chu-reims.fr   
Principal Investigator: Prof Gaetan Deslee, MD         
CHU de Rouen, Hôpital Charles Nicolle Not yet recruiting
Rouen, France, 76031
Contact: Sophie Le Parco    02 32 88 89 90    Sophie.Le-Parco@chu-rouen.fr   
Principal Investigator: Samy Lachkar         
CHU de Saint Etienne Not yet recruiting
Saint-Étienne, France
Contact: Fabrice Di Palma    04 77 82 89 34    fabrice.dipalma@hotmail.fr   
Principal Investigator: Jean-Michel Vergnon         
Germany
Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie Recruiting
Berlin, Germany
Contact: Leonore Erdmann    +4930450665038    leonore.erdmann@charite.de   
Principal Investigator: Ralph-Harto Huebner, MD         
Gemeinschaftskrankenhaus Havelhöhe GmbH Recruiting
Berlin, Germany
Contact: Conny Thieme    +49 30 36501-280    conny.thieme@havelhoehe.de   
Principal Investigator: Christian Grah, MD         
Universitätsklinkum Bonn Not yet recruiting
Bonn, Germany
Contact: Sabine Ring    +4922828714347    sabine.ring@ukb.uni-bonn.de   
Principal Investigator: Dirk Skowasch, MD         
Ruhrlandklinik Essen Not yet recruiting
Essen, Germany
Contact: Birte Schwarz    +492014334699    birte.schwarz@uk-essen.de   
Contact: Jennifer Thaelker       jennifer.thaelker@rlk.uk-essen.de   
Principal Investigator: Kaid Darwiche, MD         
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Anja Paulsen    +4940741057395    anja.paulsen@uke.de   
Contact: Ute Dickschas       ute.dickschas@uke.de   
Principal Investigator: Hans Klose, PD Dr         
Thoraxklinik Recruiting
Heidelberg, Germany
Contact: Michaela Korthöber    +4962213968253    michaela.korthoeber@med.uni-heidelberg.de   
Principal Investigator: Prof. Felix Herth, MD         
Lungenklinik Recruiting
Hemer, Germany
Contact: Katja Tietze    +49 2372 908 2169    katja.tietze@lkhemer.de   
Principal Investigator: Franz Stanzel, MD         
Klinikverbund Kempten-Oberallgäu Recruiting
Immenstädt, Germany
Contact: Simone Eberl    +49 831 530 1934    pneumologie.studien@kv-keoa.de   
Contact: Ulrike Mair       pneumologie.studien@kv-keoa.de   
Principal Investigator: Christian Schumann         
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH Recruiting
Stuttgart, Germany
Contact: Stefanie Lemmermeyer    +49 711 5533-0    stefanie.lemmermeyer@sana.de   
Principal Investigator: Martin Hetzel         
Italy
Ospedale Careggi Recruiting
Firenze, Italy
Contact: Valentina Luzzi, MD    +390557947200 ext 6208    valentinaluzzi@hotmail.com   
Principal Investigator: Michela Bezzi, MD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 3150-3610536
Contact: Karin Klooster    0031-503613279    k.klooster@int.UMCG.nl   
Contact: Jorine Hartman       j.hartman@umcg.nl   
Principal Investigator: Dirk-Jan Slebos, MD, PhD         
Switzerland
University Hospital Zürich Recruiting
Zürich, Switzerland
Contact: Daniel Franzen    +41 44 255 97 50    daniel.franzen@usz.ch   
Contact: Christina Hanna Seidel       ChristinaHanna.Roemer@usz.ch   
Principal Investigator: Daniel Franzen, MD         
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom
Contact: Chris Orton    +4420 735 180 29    c.orton@rbht.nhs.uk   
Contact: Justin Garner       j.garner@rbht.nhs.uk   
Principal Investigator: Pallav Shah         
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Felix Herth, MD, University Hospital Heidelberg
Principal Investigator: Arschang Valipour, MD,FCCP,PhD Otto-Wagner-Spital

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT03360396     History of Changes
Other Study ID Numbers: BTG-004517-01
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by PneumRx, Inc.:
severe heterogeneous emphysema
severe homogeneous emphysema

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