Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

Homogeneous Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630227
• Other study ID #: 01-C07-002
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: October 21, 2011
• Start date: February 2008
• 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 the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.

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 (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, 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 or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. 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 treated areas of the lung. This provides room within the chest to allow the remaining 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 (upper lobe predominant) 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: 33
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan

• age >/= 40 years

• clinically significant dyspnea

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

• 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:

• tobacco use within 4 months of initial visit or during study

• 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 lung perfusion scan indicating > 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema

Study Design

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

Related Conditions & MeSH terms

• Emphysema
• Homogeneous Emphysema
• Pulmonary Emphysema

Intervention

Biological:
• Biologic Lung Volume Reduction
20 mL Hydrogel

Locations

Country	Name	City	State
United States	Akron Medical Center	Akron	Ohio
United States	University of Alabama	Birmingham	Alabama
United States	Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine	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	Topeka	Kansas
United States	St Josephs 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
Secondary	improvement in exercise capacity		12 weeks post treatment	No
Secondary	improvement in expiratory flow		12 weeks post treatment	No
Secondary	improvement in vital capacity		12 weeks post treatment	No
Secondary	improvement in dyspnea sysmptoms		12 weeks post treatment	No
Secondary	improvemnet in respiratory quality of life		12 weeks post treatment	No
Secondary	serious adverse events		through 2 years	Yes