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AeriSeal System for Lung Volume Reduction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051258
First Posted: January 18, 2010
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aeris Therapeutics
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 14, 2010
First Posted: January 18, 2010
Last Update Posted: June 26, 2013
Last Verified: June 2013

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