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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00716053
First Posted: July 16, 2008
Last Update Posted: January 18, 2010
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.
Information provided by:
Aeris Therapeutics
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
  Contacts and Locations
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
First Submitted: July 15, 2008
First Posted: July 16, 2008
Last Update Posted: January 18, 2010
Last Verified: January 2010

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

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