NCT01051258

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

January 14, 2010

Last Update Submit

June 25, 2013

Conditions

EmphysemaChronic Obstructive Pulmonary Disease (COPD)Pulmonary EmphysemaLung Diseases

Keywords

Polymeric Lung Volume Reduction (PLVR)Biologic Lung Volume Reduction (BLVR)AeriSealtreatmentdevicebreathingCOPDemphysemaheterogeneoushomogeneousPathologic ProcessesRespiratory Tract DiseasesLung DiseasesPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

    12 Weeks following final treatment

Secondary Outcomes (5)

  • Change from baseline in RV/TLC ratio

    24 and 48 weeks following treatment

  • Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)

    12, 24, 48 weeks following treatment

  • Change from baseline in MRC dyspnea score

    12, 24, 48 weeks following treatment

  • Change from baseline in 6 minute walk test (MWT)

    12, 24, 48 weeks following treatment

  • Change from baseline in disease-specific health related quality of life assessment (SGRQ)

    12, 24, 48 weeks following treatment

Interventions

AeriSeal SystemDEVICE

AeriSeal System for Lung Volume Reduction

Also known as: lung volume reduction, AeriSeal, PLVR

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Otto Wagner Spital Wien Interne Lungenabteilung

Vienna, Austria

Location

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

Nice, France

Location

Chefarzt Klinik für Pneumologie

Bad Berka, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, Germany

Location

Lungenklinik Hemer

Hemer, Germany

Location

Medizinische Klinik und Poliklinik Klinikum Großhadern

München, Germany

Location

Soroka Medical Center

Beersheba, Israel

Location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

Location

Related Publications (1)

  • 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.

    PMID: 22374920DERIVED

Related Links

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic ObstructivePulmonary EmphysemaLung DiseasesRespiratory AspirationPathologic ProcessesRespiratory Tract Diseases

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease AttributesRespiration Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 18, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

April 1, 2013

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

AU(1)FR(1)DE(4)IL(2)