Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
Pulmonary Emphysema
About this trial
This is an interventional treatment trial for Pulmonary Emphysema focused on measuring BLVR, emphysema, COPD, COLD, chronic obstructive pulmonary disease, pulmonary emphysema
Eligibility Criteria
Inclusion Criteria include: Clinical diagnosis of advanced heterogeneous emphysema Age > 18 years at the time of initial presentation Clinically significant dyspnea (MRC Dyspnea >/= 2) Failure of standard medical therapy to provide relief of symptoms BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits Pulmonary function tests Exclusion Criteria: Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype Body mass index < 15 kg/m2 or > 35 kg/m2 Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis Tobacco use within 16 weeks of the initial clinic visit Allergy to fish or pork products or sensitivity to tetracycline FEV1 <20% with DLCO <20% or homogeneous disease
Sites / Locations
- Chaim Sheba (Tel Hashomer) Medical Center
Arms of the Study
Arm 1
Experimental
single
BLVR treatment