Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

Phase 2

Completed

• Conditions: Homogeneous Emphysema
• Interventions: Biological: Biologic Lung Volume Reduction

• Registration Number: NCT00630227
• 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 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.

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 (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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	Biologic Lung Volume Reduction	all patients are treated with the experimental therapy

Primary Outcome Measures

Name	Time	Method
reduction in gas trapping	12 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
improvement in exercise capacity	12 weeks post treatment
improvement in expiratory flow	12 weeks post treatment
improvement in vital capacity	12 weeks post treatment
improvement in dyspnea sysmptoms	12 weeks post treatment
improvemnet in respiratory quality of life	12 weeks post treatment
serious adverse events	through 2 years

Trial Locations

Locations (8)

Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine; 🇺🇸 Cleveland, Ohio, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States

Akron Medical Center; 🇺🇸 Akron, Ohio, United States

Temple University Lung Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Veritas Clinical Specialties; 🇺🇸 Topeka, Kansas, United States

St Josephs Medical Center; 🇺🇸 Towson, Maryland, United States