US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Completed · Phase 2

Conditions studied: Pulmonary Emphysema

In brief

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Key facts

Study ID

NCT00435253

Run by

Aeris Therapeutics

People needed

20

Starts

2007-02-01

Expected to finish

2009-06-01

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 predominant emphysema
• age >/= 40 years
• clinically significant dyspnea
• failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
• pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
• 6 Minute Walk Distance >/= 150 m

You may not qualify if…

• alpha-1 protease inhibitor deficiency
• homogeneous disease
• 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, endobronchial valve placement, airway stent placement or pleurodesis
• comorbid condition that could adversely influence outcomes
• inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

Where it is running

• University of Alabama Birmingham Lung Health Center — Birmingham, Alabama, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• Caritas St Elizabeth's Med Cen — Boston, Massachusetts, United States
• Temple University Lung Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina Hospital — 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.