Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

Completed · Phase 2

Conditions studied: Homogeneous Emphysema

In brief

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.

Key facts

Study ID

NCT00630227

Run by

Aeris Therapeutics

People needed

33

Starts

2008-02-01

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 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Veritas Clinical Specialties — Topeka, Kansas, United States
• St Josephs Medical Center — Towson, Maryland, United States
• Akron Medical Center — Akron, Ohio, United States
• Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine — Cleveland, Ohio, United States
• Temple University Lung Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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