AeriSeal System for Lung Volume Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01051258
First received: January 14, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Emphysema
Lung Diseases
Device: AeriSeal System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio [ Time Frame: 12 Weeks following final treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in RV/TLC ratio [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
  • Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator) [ Time Frame: 12, 24, 48 weeks following treatment ] [ Designated as safety issue: No ]
  • Change from baseline in MRC dyspnea score [ Time Frame: 12, 24, 48 weeks following treatment ] [ Designated as safety issue: No ]
  • Change from baseline in 6 minute walk test (MWT) [ Time Frame: 12, 24, 48 weeks following treatment ] [ Designated as safety issue: No ]
  • Change from baseline in disease-specific health related quality of life assessment (SGRQ) [ Time Frame: 12, 24, 48 weeks following treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2009
Study Completion Date: April 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AeriSeal System
    AeriSeal System for Lung Volume Reduction
    Other Names:
    • lung volume reduction
    • AeriSeal
    • PLVR
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051258

Locations
Austria
Otto Wagner Spital Wien Interne Lungenabteilung
Wien, Austria
France
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice, France
Germany
Chefarzt Klinik für Pneumologie
Bad Berka, Germany
Thoraxklinik Heidelberg
Heidelberg, Germany
Lungenklinik Hemer
Hemer, Germany
Medizinische Klinik und Poliklinik Klinikum Großhadern
München, Germany
Israel
Soroka Medical Center
Beer Sheva, Israel
Rabin Medical Center, Beilinson Hospital
Petach-Tikva, Israel
Sponsors and Collaborators
Aeris Therapeutics
  More Information

Additional Information:
No publications provided by Aeris Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01051258     History of Changes
Other Study ID Numbers: 03-C08-003PLVGP4-5, 03-C10-001PLV
Study First Received: January 14, 2010
Last Updated: June 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Austria: Agency for Health and Food Safety

Keywords provided by Aeris Therapeutics:
Polymeric Lung Volume Reduction (PLVR)
Biologic Lung Volume Reduction (BLVR)
AeriSeal
treatment
device
breathing
COPD
emphysema
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014