US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

Completed · Phase 1

Conditions studied: Pulmonary Emphysema

In brief

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

Key facts

Study ID

NCT00347659

Run by

Aeris Therapeutics

People needed

6

Starts

2006-06-01

Expected to finish

2007-09-01

Last updated by the study team

2008-03-06

Who can join

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

You may qualify if…

• Clinical diagnosis of advanced heterogeneous emphysema
• Age >/= 40
• Clinically significant dyspnea
• Failure of standard medical therapy to relieve symptoms
• Pulmonary function tests with protocol-specified ranges

You may not qualify if…

• Alpha-1 protease inhibitor deficiency
• Tobacco use within 16 weeks of initial clinic visit
• Body mass index < 15 kg/m2 or > 35 kg/m@
• Clinically significant asthma, chronic bronchitis or bronchiectasis
• Allergy or sensitivity to tetracycline
• Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

Where it is running

• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Temple University Lung Center — Philadelphia, Pennsylvania, 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.