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

January 14, 2010
June 25, 2013
November 2009
August 2011   (final data collection date for primary outcome measure)
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio [ Time Frame: 12 Weeks following final treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01051258 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
AeriSeal System for Lung Volume Reduction
A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

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

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

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Pulmonary Emphysema
  • Lung Diseases
Device: AeriSeal System
AeriSeal System for Lung Volume Reduction
Other Names:
  • lung volume reduction
  • AeriSeal
  • PLVR
Not Provided
Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2013
August 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Israel
 
NCT01051258
03-C08-003PLVGP4-5, 03-C10-001PLV
Yes
Aeris Therapeutics
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP