AeriSeal System for Lung Volume Reduction

June 25, 2013 updated by: Aeris Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Time Frame: 12 Weeks following final treatment
12 Weeks following final treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in RV/TLC ratio
Time Frame: 24 and 48 weeks following treatment
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
12, 24, 48 weeks following treatment
Change from baseline in MRC dyspnea score
Time Frame: 12, 24, 48 weeks following treatment
12, 24, 48 weeks following treatment
Change from baseline in 6 minute walk test (MWT)
Time Frame: 12, 24, 48 weeks following treatment
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
12, 24, 48 weeks following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aeris Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-C08-003PLVGP4-5
  • 03-C10-001PLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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