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

Advanced Upper Lobe Predominant Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00716053
• Other study ID #: 01-C08-001
• Status: Withdrawn
• Phase: Phase 3
• First received: July 15, 2008
• Last updated: January 14, 2010
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 225
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Upper Lobe Predominant Emphysema
• Emphysema
• Pulmonary Emphysema

Intervention

Drug:
• BLVR
BLVR 20 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pulmonary function and respiratory symptoms		6 months	No