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

Phase 3

Withdrawn

• Conditions: Advanced Upper Lobe Predominant Emphysema
• Interventions: Drug: BLVR

• Registration Number: NCT00716053
• Lead Sponsor: Aeris Therapeutics

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.

Study Timeline

• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Study Start: 2008-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLVR	BLVR	-
Saline	BLVR	-

Primary Outcome Measures

Name	Time	Method
Improvement in pulmonary function and respiratory symptoms	6 months