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Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema

Primary Purpose

Advanced Upper Lobe Predominant Emphysema

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BLVR
Sponsored by
Aeris Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Upper Lobe Predominant Emphysema focused on measuring emphysema, chronic obstructive pulmonary disease, COPD, lung volume reduction, LVRS, BLVR, Aeris

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    BLVR

    Saline

    Arm Description

    Outcomes

    Primary Outcome Measures

    Improvement in pulmonary function and respiratory symptoms

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2008
    Last Updated
    January 14, 2010
    Sponsor
    Aeris Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00716053
    Brief Title
    Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema
    Official Title
    Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    December 2009 (undefined)
    Study Completion Date
    December 2009 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Aeris Therapeutics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.
    Detailed Description
    Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications,which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk. Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs-actually using the body's natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Upper Lobe Predominant Emphysema
    Keywords
    emphysema, chronic obstructive pulmonary disease, COPD, lung volume reduction, LVRS, BLVR, Aeris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BLVR
    Arm Type
    Experimental
    Arm Title
    Saline
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    BLVR
    Intervention Description
    BLVR 20 mL
    Primary Outcome Measure Information:
    Title
    Improvement in pulmonary function and respiratory symptoms
    Time Frame
    6 months

    10. Eligibility

    Accepts Healthy Volunteers
    No

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12406835
    Citation
    Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
    Results Reference
    background
    PubMed Identifier
    17426216
    Citation
    Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
    Results Reference
    background

    Learn more about this trial

    Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema

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