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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This study has been withdrawn prior to enrollment.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

July 15, 2008
January 14, 2010
December 2008
December 2009   (final data collection date for primary outcome measure)
Improvement in pulmonary function and respiratory symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
improvement in expiratory flow [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00716053 on ClinicalTrials.gov Archive Site
Not Provided
  • improvement in vital capacity [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: No ]
  • reduction in gas trapping [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: No ]
  • improvement in dyspnea symptoms [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: No ]
  • improvement in respiratory quality of life [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: No ]
  • assessment of treatment-emergent adverse events and serious adverse events [ Time Frame: 6 months (24 weeks) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Upper Lobe Predominant Emphysema
Drug: BLVR
BLVR 20 mL
  • Experimental: BLVR
    Intervention: Drug: BLVR
  • Sham Comparator: Saline
    Intervention: Drug: BLVR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
225
December 2009
December 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00716053
01-C08-001
Yes
Program Manager, Clinical Dept.
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP