500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System
treatment plus optimal medical therapy compared in patients with advanced upper lobe
predominant (ULP) heterogeneous emphysema.
Ages:40 and older
Inclusion Criteria: - Advanced emphysema refractory to medical therapy, age ≥ 40 yrs, severe airflow obstruction and hyperinflation. - Smoking history of ≥ 20 pack-years with abstinence from at least 16 weeks prior to the initial Screening visit, confirmed by HbCO, CO, or cotinine through completion of study participation. Exclusion Criteria: - Prior thoracic surgery or endobronchial lung volume reduction, history of recurrent COPD exacerbations, disease associated with alpha-1 anti-trypsin deficiency or other co-morbid conditions that could affect study outcomes.
Sponsor: Aeris Therapeutics
Phase: Phase 3
Trial ID: NCT01449292
Not Accepting Healthy Volunteers