AeriSeal System for Lung Volume Reduction

Phase 1

Completed

• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Emphysema; Lung Diseases

• Registration Number: NCT01051258
• Lead Sponsor: Aeris Therapeutics

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2011-08
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
• Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
• Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio	12 Weeks following final treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 6 minute walk test (MWT)	12, 24, 48 weeks following treatment
Change from baseline in RV/TLC ratio	24 and 48 weeks following treatment
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)	12, 24, 48 weeks following treatment
Change from baseline in MRC dyspnea score	12, 24, 48 weeks following treatment
Change from baseline in disease-specific health related quality of life assessment (SGRQ)	12, 24, 48 weeks following treatment

Trial Locations

Locations (8)

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Otto Wagner Spital Wien Interne Lungenabteilung; 🇦🇹 Wien, Austria

Chefarzt Klinik für Pneumologie; 🇩🇪 Bad Berka, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel

Medizinische Klinik und Poliklinik Klinikum Großhadern; 🇩🇪 München, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petach-Tikva, Israel