AeriSeal System for Lung Volume Reduction

Lung Diseases Clinical Trial

Official title:

A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051258
• Other study ID #: 03-C08-003PLVGP4-5
• Secondary ID: 03-C10-001PLV
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 14, 2010
• Last updated: June 25, 2013
• Start date: November 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Ministry of HealthAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• AeriSeal System
AeriSeal System for Lung Volume Reduction

Locations

Country	Name	City	State
Austria	Otto Wagner Spital Wien Interne Lungenabteilung	Wien
France	Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice	Nice
Germany	Chefarzt Klinik für Pneumologie	Bad Berka
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Medizinische Klinik und Poliklinik Klinikum Großhadern	München
Israel	Soroka Medical Center	Beer Sheva
Israel	Rabin Medical Center, Beilinson Hospital	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Countries where clinical trial is conducted

Austria,  France,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio		12 Weeks following final treatment	No
Secondary	Change from baseline in RV/TLC ratio		24 and 48 weeks following treatment	No
Secondary	Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)		12, 24, 48 weeks following treatment	No
Secondary	Change from baseline in MRC dyspnea score		12, 24, 48 weeks following treatment	No
Secondary	Change from baseline in 6 minute walk test (MWT)		12, 24, 48 weeks following treatment	No
Secondary	Change from baseline in disease-specific health related quality of life assessment (SGRQ)		12, 24, 48 weeks following treatment	No