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Trial record 1 of 237 for:    "Emphysema"
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AeriSeal System for Lung Volume Reduction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Aeris Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01051258
First received: January 14, 2010
Last updated: March 28, 2011
Last verified: March 2011
History of Changes
  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 Airway Disease
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:

U.S. FDA Resources

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
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 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
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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Aeris Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: J.D. Bernardy/VP, Regulatory Affairs, Clinical Research & Compliance, 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: March 28, 2011
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:
emphysema
Polymeric Lung Volume Reduction (PLVR)
Biologic Lung Volume Reduction (BLVR)
AeriSeal
treatment
device
breathing
 COPD
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

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

ClinicalTrials.gov processed this record on May 21, 2013