Status:
TERMINATED
Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.
Detailed Description
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of l...
Eligibility Criteria
Inclusion
- Inclusion Criteria include:
- Clinical diagnosis of advanced emphysema
- Age \> 18 years at the time of initial presentation
- Clinically significant dyspnea (MRC Dyspnea \>/= 2)
- Laboratory tests within protocol-specified ranges
- Pulmonary function tests
- Exclusion Criteria include:
- Alpha-1 protease inhibitor deficiency verified by a serum level of \<80mg% or knowledge of PI\*ZZ genotype
- Tobacco use within 16 weeks of the initial clinic visit
- Body mass index \< 15 kg/m2 or \> 35 kg/m2
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
- Allergy to fish or pork products or sensitivity to tetracycline
- FEV1 \<20% predicted with DLCO \<20% predicted or homogeneous disease
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00205920
Start Date
May 1 2005
End Date
May 1 2007
Last Update
January 18 2010
Active Locations (1)
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1
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM