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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00716053
First received: July 15, 2008
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Advanced Upper Lobe Predominant Emphysema
Drug: BLVR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Improvement in pulmonary function and respiratory symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLVR Drug: BLVR
BLVR 20 mL
Sham Comparator: Saline Drug: BLVR
BLVR 20 mL

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.

  Eligibility

Accepts Healthy Volunteers:   No
  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.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Program Manager, Clinical Dept.
ClinicalTrials.gov Identifier: NCT00716053     History of Changes
Other Study ID Numbers: 01-C08-001
Study First Received: July 15, 2008
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:
emphysema
chronic obstructive pulmonary disease
COPD
lung volume reduction
LVRS
BLVR
Aeris

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 November 24, 2014