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

Completed · Phase 2

Conditions studied: Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00515164

Run by

Aeris Therapeutics

People needed

22

Starts

2007-08-01

Expected to finish

2009-12-01

Last updated by the study team

2011-10-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.