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

• Sponsor: Aeris Therapeutics (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00716053
• Collaborator: (none)
• Enrollment: 225
• Arms: 2
• Duration (Months): 12

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Upper Lobe Predominant Emphysema	Drug: BLVR	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 225 participants
• 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
• Study Start Date: Dec 1, 2008
• Primary Completion Date: Dec 1, 2009
• Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BLVR	Drug: BLVR; BLVR 20 mL
Sham Comparator: Saline	Drug: BLVR; BLVR 20 mL

Outcome Measures

Primary Outcome Measures

1. Improvement in pulmonary function and respiratory symptoms [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aeris Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2002 Oct 11.
• 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.

• ClinicalTrials.gov Identifier: NCT00716053
• Other Study ID Numbers: 01-C08-001
• First Posted: Jul 16, 2008
• Last Update Posted: Jan 18, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: emphysema; chronic obstructive pulmonary disease; COPD; lung volume reduction; LVRS; BLVR; Aeris
• Additional relevant MeSH terms: Pulmonary Emphysema; Emphysema

Study Results

No Results Posted as of Jan 18, 2010