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AeriSeal System for Lung Volume Reduction

Primary Purpose

Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Emphysema

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AeriSeal System
Sponsored by
Aeris Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Otto Wagner Spital Wien Interne Lungenabteilung
  • Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
  • Chefarzt Klinik für Pneumologie
  • Thoraxklinik Heidelberg
  • Lungenklinik Hemer
  • Medizinische Klinik und Poliklinik Klinikum Großhadern
  • Soroka Medical Center
  • Rabin Medical Center, Beilinson Hospital

Outcomes

Primary Outcome Measures

Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio

Secondary Outcome Measures

Change from baseline in RV/TLC ratio
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
Change from baseline in MRC dyspnea score
Change from baseline in 6 minute walk test (MWT)
Change from baseline in disease-specific health related quality of life assessment (SGRQ)

Full Information

First Posted
January 14, 2010
Last Updated
June 25, 2013
Sponsor
Aeris Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01051258
Brief Title
AeriSeal System for Lung Volume Reduction
Official Title
A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aeris Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Emphysema, Lung Diseases
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
AeriSeal System
Other Intervention Name(s)
lung volume reduction, AeriSeal, PLVR
Intervention Description
AeriSeal System for Lung Volume Reduction
Primary Outcome Measure Information:
Title
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Time Frame
12 Weeks following final treatment
Secondary Outcome Measure Information:
Title
Change from baseline in RV/TLC ratio
Time Frame
24 and 48 weeks following treatment
Title
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
Time Frame
12, 24, 48 weeks following treatment
Title
Change from baseline in MRC dyspnea score
Time Frame
12, 24, 48 weeks following treatment
Title
Change from baseline in 6 minute walk test (MWT)
Time Frame
12, 24, 48 weeks following treatment
Title
Change from baseline in disease-specific health related quality of life assessment (SGRQ)
Time Frame
12, 24, 48 weeks following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Otto Wagner Spital Wien Interne Lungenabteilung
City
Wien
Country
Austria
Facility Name
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
City
Nice
Country
France
Facility Name
Chefarzt Klinik für Pneumologie
City
Bad Berka
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik Klinikum Großhadern
City
München
Country
Germany
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach-Tikva
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
22374920
Citation
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.
Results Reference
derived
Links:
URL
http://www.aerist.com
Description
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AeriSeal System for Lung Volume Reduction

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