US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515164
• Other study ID #: 01-C07-001
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2007
• Last updated: October 21, 2011
• Start date: August 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• 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 this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.

Description:

Background:

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 which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of advanced upper lobe emphysema

• age >/= 40 years

• clinically significant dyspnea

• failure of standard medical therapy to relieve symptoms (inhaled beta agonist & inhaled anticholinergic)

• pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted & experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)

• 6 Minute Walk Distance >/= 150 m

Exclusion Criteria:

• alpha-1 protease inhibitor deficiency

• homogeneous emphysema

• tobacco use within 4 months of initial visit

• body mass index < 15 kg/m2 or> 35 kg/m2

• clinically significant asthma, chronic bronchitis or bronchiectasis

• allergy or sensitivity to procedural components

• pregnant, lactating or unwilling to use birth control if required

• prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis

• comorbid condition that could adversely influence outcomes

• inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

• history of renal infarction or renal failure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Drug:
• Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel

Locations

Country	Name	City	State
United States	Akron Medical Center	Akron	Ohio
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Temple University Lung Center	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona
United States	Veritas Clinical Specialties, Ltd	Topeka	Kansas
United States	St Joseph's Medical Center	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

United States, 

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	Reduction in gas trapping		12 weeks post treatment	No
Primary	SAEs - Safety of treatment and the procedure		2 years post treatment	Yes
Secondary	Improvement in exercise capacity		12 weeks post treatment	No
Secondary	Improvement in vital capacity		12 weeks post treatment	No
Secondary	Improvement in expiratory flow		12 weeks post treatment	No
Secondary	Improvement in inspiratory flow		12 weeks post treatment	No
Secondary	Improvement in dyspnea symptoms (breathlessness)		12 weeks post treatment	No
Secondary	Improvement in respiratory quality of life		12 weeks post treatment	No